International medical devices regulatory news-in-brief_2012 - April 2012 - Sample issue

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E-newsletter focusing on regulatory issues of medical devices with links to the sources of information
“International Medical Devices Regulatory NEWS-IN-BRIEF” is published monthly (11 issues per year)
LEGIPHARM International publishes also in French “Info Dispositifs Médicaux” and the “Brèves d’Actualités”

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International medical devices regulatory news-in-brief_2012 - April 2012 - Sample issue

  1. 1. International NEWS-IN-BRIEF – Medical Devices 2012/05/N001 April 2012 LEGIPH@RM International© LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information©
  2. 2. International NEWS-IN-BRIEF – Medical Devices 2012/05/N001 April 2012 LEGIPH@RM International© LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© International Medical Devices Regulatory NEWS-IN-BRIEF – April 2012 – N01 LEGIPH@RM International publishes “International Medical Devices Regulatory NEWS-IN-BRIEF” (IMDRNIB) a newsletter focusing on regulatory issues of medical devices. LEGIPH@RM International publishes also in French “Info Dispositifs Médicaux” and the “Brèves d’Actualités”. “International Medical Devices Regulatory NEWS-IN-BRIEF” is an electronic-only (PDF) newsletter with links to the sources of information . “International Medical Devices Regulatory NEWS-IN-BRIEF” is published monthly (11 issues per year). Subscription  Subscriptions Prices: £220; US$ 450; €313 (VAT included)  Two ways to subscribe: (1) Invoice: Email enquiry@legipharm.com and we will then send you an invoice (2) Download our subscription form, email the completed form to subscription@legipharm.com or Fax it to +33 (0)970622453.  Two ways to pay: (1) bank transfer, (2) cheque  Editorial Address: LEGIPHARM International – 4 mail Francois Mitterrand 35000 RENNES – France  Billing Address: LEGIPHARM International – 4 mail Francois Mitterrand 35000 RENNES – France  Editorial Board: Chairman Bernard-Régis Durand – Editor Thérèse Pierre  Contact: info@legipharm.com –Tel +33 (0)299388474 (The office is open Monday through Friday from 9:30 am - 6:00 pm – European Time) Newsletter Disclaimer  General: Whilst making all reasonable efforts to provide correct information, LEGIPHARM International cannot guarantee that the information and data provided by the IMDRNIB newsletter are accurate. The IMDRNIB newsletter is not intended to provide advice with respect to any specific matter. Whilst every effort has been made to ensure the accuracy of this publication, it is for general guidance only and should not be treated as a substitute for specific advice. No warranty of any kind is given with respect to the mentioned information and data. Therefore, LEGIPHARM International shall have no liability or responsibility whatsoever no matter whether it is based on contract, tort or any other legal ground for any inaccuracy, incompleteness, omission, lack of timeliness or any other error of the data and information nor for any computer viruses transferred with the data supplied by LEGIPHARM International in the IMDRNIB Newsletter. Decisions based on data and information contained in the IMDRNIB newsletter are the sole responsibility of the user.  Links: LEGIPHARM has checked the links (URL) mentioned in the IMDRNIB newsletter, but LEGIPHARM is not responsible for (1) any subsequent changes to the Web sites after the publication of the IMDRNIB newsletter, (2) any broken links, (3) any impossibility to access the mentioned URL of the websites.  Translation: The IMDRNIB newsletter have been prepared for information purposes only. When an English translation is provided by LEGIPHARM, this translation is also for information purposes only. LEGIPHARM is therefore not liable for any inaccurate information resulting from the translation. The translation is not a substitute for the original version. Copyright: © 2012  All rights reserved. Only the subscribers who have access to the IMDRNIB newsletter are permitted to access, store, print the IMDRNIB newsletter. The subscribers are not permitted to transmit the IMDRNIB newsletter in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without prior permission of LEGPHARM. Date of Information  Information is sorted by date. These dates may be (1) the date specified in the source document itself, (2) the date of creation of the source document file, (3) the date of the last modification of the source document file, (4) the date of the emailing of the source document, (5) the date of the source document specified in the website or (6) the date on which LEGIPHARM has discovered the existence of the source document. 
  3. 3. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Contents -Page 1 April 2012 LEGIPH@RM International© International Medical Devices Regulatory NEWS-IN-BRIEF International Medical Devices Regulatory NEWS-IN-BRIEF ................................................................................................ 1 April 15, 2012..................................................................................................................................................................... 1  Brazil – LNE/G-MED America: Medical Devices Approval Process ...........................................................................................1  International ISO: ISO standards updates and medical devices ............................................................................................1 April 14, 2012..................................................................................................................................................................... 1  Europe / European Commission: A new version of the Borderline manual...............................................................................1 April 13, 2012..................................................................................................................................................................... 1  Australia – Therapeutic goods administration (TGA): PIP breast implants – information update ................................................1  Korea – KFDA: Regulations and adverse event reporting......................................................................................................1 April 12, 2012..................................................................................................................................................................... 2  China – Clinical trial: OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions ............................................2 April 11, 2012..................................................................................................................................................................... 2  European Federation of pharmaceutical industries and associations (EFPIA): Industry Perspective on Formulation and Packaging Considerations – Devices (Integrated Product) Aspects........................................................................................................2  Europe – Official Journal of the European Union: Harmonised standards, electromagnetic compatibility and medical devices ........2  Europe – Official Journal of the European Union: Harmonised standards, radio equipment and telecommunications terminal equipment and medical devices ........................................................................................................................................2  Europe – European Commission: European Commissioner for Research, Innovation and Science, Ireland, Medtronic and medical devices..........................................................................................................................................................................3  US – Clinical trials: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation ....4 April 10, 2012..................................................................................................................................................................... 4  Europe – European Databank on Medical Devices (EUDAMED): Deadline for data on registration of medical devices manufacturers ....................................................................................................................................................................................4  Japan – Clinical trials: Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS ................................4  Japan – Clinical trials: Multi-center Study for Stent Graft System for Peripheral Artery ............................................................5  United-Kingdom – Clinical trials: Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis .................................................................................................................................................................5 April 10, 2012..................................................................................................................................................................... 5  Australia – Therapeutic goods administration (TGA): PIP breast implants – TGA update...........................................................5  Malaysia – Medical Device Control Division (MDCD) of the Ministry of Health: The Medical Device Act 2012 and the Medical Device
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LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Contents -Page 2 April 2012 LEGIPH@RM International© Authority Act 2012 have been gazetted .............................................................................................................................5 April 9, 2012....................................................................................................................................................................... 6  China – Clinical trials: Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union ...........6 April 4, 2012....................................................................................................................................................................... 6  United-Kingdom – MHRA: Weekly list of Field Safety Notices 2 – 6 April 2012 ........................................................................6 April 4, 2012....................................................................................................................................................................... 7  Europe – Notified Bodies: LGA InterCert Medical and TÜV Rheinland LGA Products become one ................................................7 April 3, 2012....................................................................................................................................................................... 7  Brazil – Ministry of Health: National health products and preference in federal procurement.....................................................7  Australia – Therapeutic goods administration (TGA): Brochure for health professionals about reporting medical device adverse incidents........................................................................................................................................................................7 April 2, 2012....................................................................................................................................................................... 7  Spain – Spanish Agency for Medicines and Healthcare Products: increasing activated for medical devices ..................................7  Australia – Therapeutic goods administration (TGA): PIP breast implants – Progress review of on-going TGA Laboratory testing program ........................................................................................................................................................................8  United-Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA): New advice to surgeons about metal-on-metal total hip replacements.....................................................................................................................................................9  Canada – Health Canada: Medical Device Recall Listings Date April 2012 – June 2012 ...........................................................10  Canada – Health Canada: Revisions made to guidance documents and forms for medical devices –fees...................................10 March 30, 2012................................................................................................................................................................. 11  Australia – Medical technology association of australia (MTAA): Medical technology industry a key to economic growth in Australia ..................................................................................................................................................................................11  Australia – Therapeutic goods administration (TGA): PIP breast implants – Information update ..............................................12  US – Food and Drug Administration (FDA): The safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems ......12  Japan – Ministry of health: Regenerative products and medical devices ...............................................................................14  United-Kingdom – MHRA: Weekly list of Field Safety Notices 26 – 30 March 2012.................................................................14 March 29, 2012................................................................................................................................................................. 14  International – International Organisation for Standardisation: An ISO/IEC guide upgrades safety aspects in medical device standards ....................................................................................................................................................................14  Ireland parliament: PIP breast implants and the the revision of the medical devices legislation...............................................15  United Kingdom – Health and Safety Executive (HSE) / Medicines and Healthcare Products Regulatory Agency (MHRA): Arrangements for liaison between the HSE and the MHRA, Medical Devices Division ..............................................................15  Europe - Official Journal of the European Union: Regulation on electronic instructions for use of medical devices ......................16
  5. 5. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Contents -Page 3 April 2012 LEGIPH@RM International© March 28, 2012................................................................................................................................................................. 16  United-Kingdom – parliament Health Committee: All providers should offer to replace breast implants which have failed according to Health Committee .....................................................................................................................................................16  United-Kingdom – Parliament: PIP Breast Implants and regulation of cosmetic interventions..................................................16 For further information..................................................................................................................................................... 16  US – Food and Drug Administration (FDA): ISO 13485:2003 Voluntary Audit Report Submission Pilot Program ........................17  US – Food and Drug Administration (FDA): New FDA guidance on considerations used in device approval, de novo decisions – Clinical data, risks, benefits and patient risk tolerance outlined in process............................................................................17  US – Food and Drug Administration (FDA): General issues related to medical devices intended for obese patients ....................18  Europe – European Medicines Agency (EMA): “Explanatory note on fees payable to the European Medicines Agency” and “Consultation on ancillary substances including blood derivates incorporated in medical devices”............................................18 March 27, 2012................................................................................................................................................................. 19  Europe – European Association for Medical Devices of Notified Bodies: European Medical Device Notified Bodies Statement on European Medical Device Regulatory Regime....................................................................................................................19  Argentina – Ministry of health: Free Hearing aids and cochlear implants and promotion of social integration of deaf children......19  Europe – European Association for Medical Devices of Notified Bodies: Statement on European Medical Device Regulatory Regime ..................................................................................................................................................................................20 March 26, 2012................................................................................................................................................................. 20  United-Kingdom – Parliament: Regulation of medical implants............................................................................................20  International – International Criminal Police Organization (INTERPOL): A fact sheet about pharmaceutical crime......................20  Argentina – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT): A partnership agreement with a e-commerce leader firm in Latin America to control internet sales of drugs and medical products ...........................................21 March 23, 2012................................................................................................................................................................. 21  US – Food and Drug Administration (FDA): Safety and effectiveness of two transcatheter Atrial Septal Defect (ASD) occluders ..21  Norway – Health directorates: New measures for breast reconstruction ...............................................................................21  United–Kingdom: Weekly list of Field Safety Notices 19 – 23 March 2012 ............................................................................21 March 22, 2012................................................................................................................................................................. 22  China – Sate Food and drugs administration (SFDA): Meeting with European Commissioner for Health and Consumer Policy and Director General of European Commission DG Health and Consumers..................................................................................22  Brazil – Agência Nacional de Vigilância Sanitária (ANVISA) / National Agency of Sanitary Surveillance: International experts and Brazilian monitoring of orthopedic implants......................................................................................................................22 March 22, 2012................................................................................................................................................................. 22  Brazil – Agencia Nacional de vigilancia sanitaria (ANVISA): The Agency publishes rules on breast implants ..............................22
  6. 6. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Contents -Page 4 April 2012 LEGIPH@RM International© March 19, 2012................................................................................................................................................................. 23  International – World Health Organisation: Effective approaches for strengthening multisectoral action for noncommunicable diseases and medical devices .........................................................................................................................................23 March 16, 2012................................................................................................................................................................. 23  US – Food and Drug Administration (FDA): Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability ...................................................................................................................................................................23  US – Food and Drug Administration (FDA): Modifications to the List of Recognized Standards ................................................23 Le 15 march 2012 ............................................................................................................................................................. 24  Netherlands – Healthcare Inspectorate: Breast implants PIP...............................................................................................24  Singapore – Health Sciences Authority: Regulatory controls for medical devices used in clinical trials in Singapore ...................24  Ukraine – State administration of Ukraine on medicinal products: In Ukraine mostly authorized medical devices are produced in Germany .....................................................................................................................................................................24  International – International Medical Device Regulators Forum (IMDRF): Five work items agreed for international progression...25
  7. 7. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 1 April 2012 LEGIPH@RM International© International Medical Devices Regulatory NEWS-IN-BRIEF April 15, 2012  Brazil – LNE/G-MED America: Medical Devices Approval Process  LNE/G-MED, a Notified Body on medical devices has written a detailed guide to the Brazilian medical device registration and marketing process. The Guide covers all the major medical device regulations in Brazil and outlines the process that manufacturers take to register and market their device.  “Get your FREE Guide”  http://www.lne-america.com/quality-news-faqs/free-guide-brazil-md-approval.html  International ISO: ISO standards updates and medical devices  Supplement to ISO Focus –April 2012  This supplement contains information about ISO medical devices Standards “in process”: “Quality management and corresponding general aspects for medical devices”, “Anaesthetic and respiratory equipment”, “Prefilled syringes”, “Needle-based injection systems for medical use”, “Medical products containing viable human cells”, “Sterilization of health care products”, “Medical devices — Hierarchical coding structure for adverse events” […]  http://www.iso.org/iso/isoupdate_april2012.pdf April 14, 2012  Europe / European Commission: A new version of the Borderline manual  Manual on borderline and classification in the community regulatory framework for medical devices – Version 1.12 (04-2012)  The European Commission issues new version of the Borderline manualNew: “Air purifiers / Air decontamination units / Mobile air decontamination Units”, “Wigs and head scarves”  http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf April 13, 2012  Australia – Therapeutic goods administration (TGA): PIP breast implants – information update  PIP breast implants – TGA update  Updated information on safety concerns with PIP breast implants: 250 Confirmed ruptures and 38 Unconfirmed ruptures  http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120413.htm  Korea – KFDA: Regulations and adverse event reporting  Regulations and medical device adverse event reporting (safety information, adverse event evaluation criteria and evaluation methods…) (In Korean)  http://www.kfda.go.kr/search/search.kfda?mid=283&mscode=CA02&cdcode=8,9,15,16&uid=3  http://www.kfda.go.kr/index.kfda?mid=95&seq=3902&cmd=v
  8. 8. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 2 April 2012 LEGIPH@RM International© April 12, 2012  China – Clinical trial: OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions  OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions (OPOV) – This study is ongoing, but not recruiting participants.  Purpose: OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive. The comparator is a standard care treatment regime comprising tape and gauze.  Sponsor: Smith & Nephew Medical (Shanghai) Ltd  Location: China  http://clinicaltrials.gov/ct2/show/NCT01577225?rcv_d=14&lup_s=03%2F15%2F2012&lup_d=30 April 11, 2012  European Federation of pharmaceutical industries and associations (EFPIA): Industry Perspective on Formulation and Packaging Considerations – Devices (Integrated Product) Aspects  Industry Perspective on Formulation and Packaging Considerations by Ron Ogilvie (Pfizer) – EFPIA – February 2012  […] Devices (Integrated Product) Aspects: Medical devices (and integrated products – e.g. inhaled products etc.) are designed to be suitable for the user. (1) This includes risk-based design validation and ‘human factor’ testing (useability engineering) – EN 62366 – Medical device useability engineering – ISO 14371 – Risk management of medical devices. (2) Includes consideration of all potential users – If a geriatric use was perceived this potential use would be designed in or tested for with representative group of users  http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/04/WC500125148.pdf  Europe – Official Journal of the European Union: Harmonised standards, electromagnetic compatibility and medical devices  Official Journal of the European Union 11.4.2012 – Commission communication in the framework of the implementation of Directive 2004/108/EC of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (Text with EEA relevance) – Publication of titles and references of harmonised standards under the directive  EN 55011:2007: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement  EN 55011:2009: Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement CISPR 11:2009 (Modified)  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:104:0038:0058:EN:PDF  Europe – Official Journal of the European Union: Harmonised standards, radio equipment and telecommunications terminal equipment and medical devices  Official Journal of the European Union 11.4.2012 – Commission communication in the framework of the implementation of the Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (Text with EEA relevance) (Publication of titles and references of harmonised standards under the directive) (2012/C 104/01)  EN 300 674-2-1 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Road Transport and Traffic Telematics (RTTT); Dedicated Short Range Communication (DSRC) trans- mission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive; Sub-part 1: Requirements for the Road Side Units (RSU)
  9. 9. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 3 April 2012 LEGIPH@RM International©  EN 300 674-2-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Road Transport and Traffic Telematics (RTTT); Dedicated Short Range Communication (DSRC) trans- mission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive; Sub-part 2: Requirements for the On-Board Units (OBU)  EN 301 489-27 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)  EN 301 489-29 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands  EN 301 489-31 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)  EN 301 839-2 V1.3.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive  EN 302 195-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories;Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive  EN 302 510-2 V1.1.1: Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive  EN 302 537-2 V1.1.2: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:104:0001:0037:EN:PDF  Europe – European Commission: European Commissioner for Research, Innovation and Science, Ireland, Medtronic and medical devices  Opening remarks – Turning of the sod ceremony for the construction of the new Customer Innovation Centre at Medtronic – Máire Geoghegan- Quinn – European Commissioner for Research, Innovation and Science – Galway, 11 April 2012  […] Medtronic is a global leader in medical technology, employing 36,000 people, with over 2,000 people based in Galway. This new centre is a testament to Medtronic's commitment to working with clinicians, surgeons, researchers and patient groups in the development of new technology so as to improve the quality of health for patients throughout the world. […] The centre will build on the very strong expertise and proven record that Medtronic has in bringing new innovative medical devices into the marketplace, and once completed, it will attract the best scientists and researchers from all parts of the world to Galway. This new centre will feature state-of-the-art facilities, including a virtual cath lab, a wet lab and an innovation workshop. […]  Medical technology is a highly significant industrial sector for Europe, most notably in terms of employment, innovation and quality of life. There are around 22,500 medical technology companies in Europe, employing approximately 500,000 people. These companies have combined annual sales of 95 billion Euro with, on average, 6 to 8% of this being re-invested in R&D. This strong innovative character is reflected by the fact that more than 80% of these MedTech companies are SMEs.  Ireland is a leader in the MedTech sector, employing the highest per capita of medical technology personnel in Europe. Eight of the top twenty global MedTech companies have a manufacturing base here. Over 40 years experience has resulted in a dynamic, well serviced sector and a globally recognised centre of excellence.  The Galway MedTech cluster is an example of a vibrant place for stimulating innovation and promoting entrepreneurial activities in the sector, thanks to multiple interfaces and the presence of academic and private research centres nearby. Together with the support from the National University of Ireland, Galway, there are now approximately 40 MedTech SMEs located here. […]  A particular characteristic of the sector is that product development times are significantly shorter than in other fields and the lifecycle for MedTech products is, on average, only 18 months. Therefore, Medical Technologies may serve as a model for spurring the innovation cycle and strengthening European competitiveness.  Medical Technologies have great potential for increasing competitiveness, innovation and growth in Europe. The strong presence of SMEs in the sector complements the establishment of "Innovation Union", which is one of the EU's central policies for growth and jobs.  Medical technologies also have the potential to play an important role in the new European Innovation Partnership on "Active and Healthy Ageing" that aims to encourage the uptake of research results and deliver new products and healthcare solutions into the marketplace.
  10. 10. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 4 April 2012 LEGIPH@RM International©  Medical technologies will also be supported under Horizon 2020, our new European programme to boost research and innovation. They will find a place in all three pillars of the programme: under pillar one on developing Scientific Excellence; under pillar two on delivering Industrial Leadership by supporting key enabling technologies; and under pillar three on tackling Societal Challenges in the thematic areas of health, demographic change and well-being. […]  http://ec.europa.eu/ireland/press_office/news_of_the_day/word_docs/2012/20120411_speech_galway-medtronic.doc  US – Clinical trials: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation  Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation. This study is enrolling participants by invitation only.  Purpose: The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device – VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.  Condition: Heart Failure  Sponsor: Virginia Commonwealth University  http://clinicaltrials.gov/ct2/show/NCT01576562 April 10, 2012  Europe – European Databank on Medical Devices (EUDAMED): Deadline for data on registration of medical devices manufacturers  Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) – (2010/227/EU)  Reminder of Article 5: As concerns data existing before the date referred to in Article 6 (1 May 2011), Member States shall ensure that the data on registration of manufacturers, authorised representatives and devices are entered into Eudamed in accordance with Article 14a(1)(a) of Directive 93/42/EEC and Article 12(1)(a) of Directive 98/79/EC. That data shall be entered by 30 April 2012 at the latest.  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF  Article 14a(1)(a) of Directive 93/42/EEC: Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a wellinformed basis. The databank shall contain the following: (a) data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices […]  Article 12(1)(a) of Directive 98/79/ECArticle 12: Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. The databank shall contain the following: (a) data relating to registration of manufacturers and devices in accordance with Article 10 […]  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF  Japan – Clinical trials: Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS  Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience/PROMUS (BEGIN)  Purpose: The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience/PROMUS) in patients with de novo true bifurcation lesions. The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.  Condition: Coronary Stenosis  Intervention: Device: 2-link stent Nobori and 3-link stent Xience/PROMUS  Sponsor: Kurashiki Central Hospital  Location: Japan  http://clinicaltrials.gov/ct2/show/NCT01574586
  11. 11. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 5 April 2012 LEGIPH@RM International©  Japan – Clinical trials: Multi-center Study for Stent Graft System for Peripheral Artery  Multi-center Study for Stent Graft System for Peripheral Artery – Condition: Symptomatic Peripheral Arterial Disease Intervention: Device: GP1101 Sponsor: W.L.Gore & Associates Recruiting – verified April 2012  Purpose: The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.  Condition: Symptomatic Peripheral Arterial Disease  Sponsor: W.L.Gore & Associates  Locations: Japan  http://clinicaltrials.gov/ct2/show/NCT01575808  United-Kingdom – Clinical trials: Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis  Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis – This study has been completed  Purpose: When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. […]  Sponsor: Queen Margaret University  Collaborators: DePuy International – Royal Infirmary of Edinburgh  Locations: United Kingdom  http://clinicaltrials.gov/ct2/show/NCT01576445 April 10, 2012  Australia – Therapeutic goods administration (TGA): PIP breast implants – TGA update  PIP breast implants – TGA update – april 2012  Number of instances of ruptured PIP breast implants notified to the TGA as of 4 April 2012: 220 confirmed ruptures and 31 unconfirmed ruptures  http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120405.htm  Malaysia – Medical Device Control Division (MDCD) of the Ministry of Health: The Medical Device Act 2012 and the Medical Device Authority Act 2012 have been gazetted  MDCD informs that the Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738 have been gazetted on 9th February, 2012.  The Acts can be downloaded via the following website; http://www.federalgazette.agc.gov.my/eng_main/main_akta.php?jenis_akta=Baru.  http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=38&Itemid=95 Further information  Act 737 will come into effect later this year and undergoes a transition period before it is fully enforced in two years’ time (2014). The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration. Whereas Act 738 details out the organisation of a regulatory body that will implementing Act 737.
  12. 12. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 6 April 2012 LEGIPH@RM International©  Currently, [MDCD is] undergoing drafting of its Subsidiary Legislations and Guidelines. Once the effective date is announced, medical devices are required to be registered and establishments will be licensed. All conformity assessment bodies will also be registered during the transition period.  The MDCD would like to inform that it has not given out any appointment to any person or company on its behalf to conduct quality management system (QMS) audit based on ISO 13485 or Good Distribution Practice for Medical Device (GDP MD). You are advised to refrain from entering any contractual agreement when approach by such person or organisation. Announcements will be made from time to time with regards to the status of the Act and its Subsidiary Legislations.  http://www.federalgazette.agc.gov.my/outputaktap/20120209_738_BI_JW001759%20Act%20738(BI).pdf  http://www.federalgazette.agc.gov.my/outputaktap/20120209_737_BI_JW001759%20Act%20737%20(BI).pdf April 9, 2012  China – Clinical trials: Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union  Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union – This study has been completed.  Purpose: The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.  Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School  Locations: China, Jiangsu Province  http://clinicaltrials.gov/ct2/show/NCT01574833 April 4, 2012  United-Kingdom – MHRA: Weekly list of Field Safety Notices  United-Kingdom – MHRA: Weekly list of Field Safety Notices 2 – 6 April 2012  Baxter Healthcare: Dialysis, peritoneal tubing set. UV HomeChoice Automated PD set with cassette 4-prong, HomeChoice automated PD set with cassette 4-prong and 8-prong, 5-prong manifold set with System II connectors.  DePuy Orthopaedics: Spinal implants; pedicle screw. Fenestrated screw open alignment guide.  DePuy Orthopaedics: Surgical instruments, implant knee prosthesis impactor. Attune impaction handle (254401010).  Edwards Lifesciences: Implants, non active, cardiovascular heart valves; percutaneous transcatheter delivery system. Edwards Lifesciences Ascendra2 Transapical Delivery System, Model numbers: 9350AS23 & 9350AS26, Lot numbers: 59191159 & 59191164.  Ethicon Endo-Surgery: Surgical instruments, non articulated cutting blade. Blade - Harmonic® hand piece Harmonic® Blue hand piece and Blue test tip.  Greiner Bio-One: Surgical instruments, miscellaneous, blood sample collection equipment. Vacuette Quickshield Complete Plus.  IDEV Technologies: Implants, non active, peripheral vascular stents. Super Veritas self-expanding Nitinol stent peripheral vascular & biliary system.  Stryker Medical: Beds and accessories; bed. Stryker Medical Epic critical care beds, Epic Zoom critical care beds and Secure II beds - Models 2030, 2040, 3002 and 220 /230 Volt Bed Models 2031 and 3221.  Stryker Orthopaedics: Joint prosthesis, hip prosthesis. Mitch TRH acetabular cup/Mitch TRH modular head when implanted with the uncemented Accolade femoral stem.  Teleflex: Airway devices; guedel airways. Hudson RCI BiteGard oral bite block.  Rocket Medical: Chest drains and accessories underwater chest drainage bottle. R54546.  Woodway: Therapy, standing & walking tread mill. All PPS series models (PPS ortho, PPS med and PPS plus) equipped with a motor controller type "Quantum" B3215 Firmware Rev. "F".  http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON149596
  13. 13. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 7 April 2012 LEGIPH@RM International© April 4, 2012  Europe – Notified Bodies: LGA InterCert Medical and TÜV Rheinland LGA Products become one  The medical divisions of the TÜV Rheinland companies LGA InterCert and TÜV Rheinland LGA Products will join forces. Thus, LGA InterCert’s Notified Body for medical devices will be integrated into the Notified Body TÜV Rheinland LGA Products GmbH. As a consequence the testing, auditing and certification of medical devices will in the future be carried out by one single Notified Body. This consolidation will result in one of the largest Notified Bodies for medical devices, which is able to offer its customers security and continuity, due to the size and international orientation of the company. This is particularly relevant in times of structural changes in the EU’s medical device legislation and the call for higher requirements.[…]  http://www.tuv.com/news/en/corporate/about_us_1/press/news_2/newscontent_cw_95333.jsp/LGA%20InterCert%20Medical%20and%20T%C3%9CV%20Rheinlan d%20LGA%20Products%20become%20one April 3, 2012  Brazil – Ministry of Health: National health products and preference in federal procurement  COMPLEXO INDUSTRIAL – Produtos nacionais terão preferência em compras (in Portuguese)  Domestic products shall have preference in purchasing: More than 120 health products produced in the country will have preference in federal procurement. Measure will stimulate investment and innovation in Brazil, and reduce dependence on imports […] investments and partnerships: The Ministry of Health is developing several initiatives to strengthen the domestic industry, and stimulate productive development and innovation. […] These agreements cover the manufacture of biological products (for rheumatoid arthritis, genetic diseases and cancer), medicines for so-called "neglected diseases" and equipment, especially in the field of orthotics and prosthetics. […] The savings generated by these partnerships is $ 400 million a year on procurement.  http://portalsaude.saude.gov.br/portalsaude/noticia/4697/162/produtos-nacionais-terao-preferencia-em-compras.html  Australia – Therapeutic goods administration (TGA): Brochure for health professionals about reporting medical device adverse incidents  Reporting medical device adverse incidents – Brochure for health professionals about reporting medical device adverse incidents  Introduction: The TGA's Office of Product Review developed the brochure below to encourage health professionals to report adverse events or incidents related to the use of medical devices. Health professionals have expert knowledge related to device use and safety and are likely to observe adverse incidents associated with the use of medical devices. Reports of adverse events submitted by health professionals contribute to the ongoing collection of information that occurs once medical devices are on the market.  Content: “Who can report on an adverse event?”, “Your role in reporting an adverse event”, “What should you include?”, “What happens to the report at the TGA?”, “How you can report”  http://www.tga.gov.au/hp/problem-device-reporting-incidents.htm  http://www.tga.gov.au/pdf/hp-problem-device-reporting-incidents.pdf (november 2011) April 2, 2012  Spain – Spanish Agency for Medicines and Healthcare Products: increasing activated for medical devices  Lunes, 2 de abril de 2012 – La Agencia Española de Medicamentos y Productos Sanitarios incrementa su actividad en todas sus áreas – The Spanish Agency for Medicines and Healthcare Products increased its activity in all areas
  14. 14. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 8 April 2012 LEGIPH@RM International©  Medical Devices: In the field of medical devices, the Competent Authority, acting as a Notified Body, granted the CE conformity marking to 213 products (486 variants) and extended the CE [Mark] to 121 products (337 variants), making 119 quality audits of manufacturers. As for the performances of surveillance devices, the Competent Authority receives reports of adverse events and safety corrective action by manufacturers, managing the Monitoring System Devices and transmitting alerts to the regions. This activity showed a significant increase over previous years, with 2,378 notifications received during the years 2011 and 638 alerts transmitted (16% on the year 2010). He also recorded a significant increase in the activity of market surveillance to detect non-compliant medical devices and illegal.  http://www.lamoncloa.gob.es/ServiciosdePrensa/NotasPrensa/MinisterioSanidadServiciosSocialesIgualdad/2012/020412-medicamentos.htm For further information  Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) – Memoria de actividades 2011d  A chapter of the AEMPS Activities Report 2011 deals with medical devices  http://www.aemps.gob.es/laAEMPS/memoria/docs/memoria-2011.pdf  Australia – Therapeutic goods administration (TGA): PIP breast implants – Progress review of on-going TGA Laboratory testing program  PIP breast implants – TGA update – This TGA update discusses on “Progress review of on-going TGA Laboratory testing program”  URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120402.htm Some excerpts  PIP breast implants: AFSSAPS has reported that there are at least three different formulations of filler gel used in PIP breast implants. The different formulas are detailed in the table below. According to AFSSAPS, the authorised gel was manufactured with NUSIL 3MED6300 gel, while the unauthorised gels were manufactured using a combination of other brands of silicone raw materials, with two different formulations identified as PIP1 and PIP2. Apparently, PIP1 was manufactured prior to 2008 and PIP2 from the beginning of 2008. It is not clear when NUSIL was used to manufacture the gel used in PIP breast implants, but it appears that this gel was used in micro-textured PIP breast implants after the middle of 2006, although this type of implant does not appear to have been supplied in Australia. NUSIL PIP 1 PIP 2 Manufactu rer of raw materials Nusil Bluestar – Rhodorsil product Momentive – Silopi product Bluestar – Rhodorsil product Momentive – Silopi product Silicone oil trimethylated Silopi (W1000) or Rhodorsil (H47V1000) 94.3% Silicone oil trimethylated Silopi (W1000) or Rhodorsil (H47V1000) 90.2% Vinyl terminated silicone oil Silopi (U165) 4.4% Vinyl terminated silicone oil Silopi U165 8.3% Rhodorsil RTV 141 Part A 1.1% Rhodorsil RTV 141 Part A 1.1% Rhodorsil RTV 141 Part B 0.2% Rhodorsil RTV 141 Part B 0.4% Formula NUSI L 3 MED 6300 100% Ratio of Rhodorsil RTV A:B = 5.5 compared to manufacturer's recommendation of 10 Ratio of Rhodorsil RTV A:B = 2.75 compared to manufacturer's recommendation of 10  TGA Laboratory testing plan –Range and number of samples: The TGA testing program has used samples from the broadest cross-section of batches and models of PIP breast implants available to the TGA, and has also tested batches of other brands of breast implant for comparison.The TGA is also testing different silicone raw materials that have been used in the manufacture of the silicone gel in the PIP breast implants. To date, TGA has received 19 different batches (29 samples), from the Australian market, and 5 batches (23 samples), from overseas, of PIP breast implants. Findings from testing these batches build on the testing of around 30 batches by AFSSAPS and the results reported by the MHRA.By way of example, AFSSAPS used 5 batches in an 'elongation test' and 4 batches in an 'intradermal irritation test'. The TGA further investigated those tests by testing 13 batches in the elongation test and 7 batches in the intradermal irritation test (in studies TGA commissioned both in Australia and in Europe). To date, the TGA has also conducted tests on 14 PIP breast implants that have been surgically removed (explanted) to provide further evidence that will assist with determining the overall quality and safety of the product. The TGA is not aware of any regulator from any other country that has reported results from testing explanted PIP breast implants.
  15. 15. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 9 April 2012 LEGIPH@RM International©  TGA Laboratory testing plan –Testing regime: Since the original advice was that PIP breast implants had been manufactured with unauthorised silicone gel filler, initial testing focussed on establishing the physical and mechanical properties, as well as the toxicity of the implants. Subsequent reports, particularly in February and March 2012, presented clearer details of the findings from laboratory testing commissioned by AFSSAPS. Consequently, TGA focussed its laboratory investigations on: “the irritant potential of the shell and gel used in PIP breast implants”, “chemical toxicity, including presence of metals”, “mechanical characteristics of the shell, with special regard to the tensile elongation test”, “mechanical characteristics of the filler gel, with special regard to the firmness and cohesiveness of the gel”, “chemical analysis of the gel, especially determining the presence of low molecular weight silicones”, “other physico-chemical features of the gels, especially thermogravimetric behaviour”, “investigation of explanted PIP breast implants”. […] Study Test Toxicology  Intra-dermal irritation – ISO 10993-10: 2010  Cytotoxicity – ISO 10993-5:2009 Chemical analysis  Chemically fingerprinting using Fourier transform infrared spectroscopy (FTIR)  Chemically profiling using gas chromatography-mass spectrometry (GC-MS), thermogravimetric analysis (TGA) and gel permeation chromatography (GPC).  Presence and quantification of D4-D6 siloxanes using headspace and direct injection GCMS.  Presence of metals using inductively coupled plasma mass spectrometry (ICP-MS) Physico-mechanical tests  Tensile Elongation – ISO 14607:2007 Annex B Section 1.2  Tensile Set – ISO 14607:2007 Annex B Section 1.3  Strength of joints, seams and seals – ISO 14607:2007 Annex B Section 2  Silicone Gel Cohesion – ISO 14607:2007 Annex D Section 4&5 Testing on explanted PIP implants  Visual examination with photography and microscopy, as well as chemical and mechanical analysis as appropriate.  Findings from testing –Summary: (1) While AFSSAPS reported a 'potential irritant' finding for the filler silicone gel, this is not consistent with testing results from studies commissioned by the TGA. Two different laboratories (in Australia and Europe) carried out tests in accordance with the international standard and results from both laboratories indicated that the gel and the shell of tested PIP breast implants were non-irritant. (2) Testing by the TGA, MHRA and AFSSAPS has not shown chemical toxicity to living cells (cytotoxicity). Furthermore, testing by AFSSAPS and MHRA has not shown toxicity to DNA within the genetic machinery of the cell (genotoxicity). (3) Consistent with reports by AFSSAPS, the TGA has noted that there is variability in the physico- chemical characteristics of different batches of PIP breast implants. (4) Questions have been raised about the amount of small molecular weight silicones (D4-D6 siloxanes) that may be present in unauthorised gels. To date, chemical testing indicates that the amount of these siloxanes in PIP breast implants is not a safety concern. (5) Testing has not identified any metals in the tested PIP breast implants that are at a level of concern. (6) The TGA testing did not identify problems regarding shell integrity, although AFSSAPS reported failures related to the tensile elongation test. (7) While TGA investigations generally found filler gels to be suitably firm and cohesive, some PIP breast implants appear to be less firm. […]  URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120402.htm  United-Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA): New advice to surgeons about metal-on-metal total hip replacements  Press release -MHRA issues new advice to surgeons about metal-on-metal total hip replacements – Date:2 April 2012  Text: The Medicines and Healthcare products Regulatory Agency (MHRA) today issued advice to surgeons to stop using a particular combination of metal-on-metal total hip replacements because it has a high revision rate compared with other implants. The MHRA has also advised surgeons to closely monitor patients with this combination of implants. The advice is included in a new MHRA Medical Device Alert that has been issued to clinicians today for the management of patients the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics. Surgeons are being advised to stop using this combination of hip replacements because information from the England and Wales National Joint Registry (NJR) shows that it has an unacceptably high revision rate of 10.7 percent after four years of implantation. The MHRA is advising surgeons to follow up with patients with this combination of devices as we previously advised in February 2012. The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. Patients with the MITCH TRH resurfacing implants are not affected by this latest notification. There are around 270 people with this combination in England and Wales according to the NJR. Dr Susanne Ludgate, Clinical Director of the
  16. 16. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 10 April 2012 LEGIPH@RM International© MHRA, said: “The majority of patients implanted with metal-on-metal hip replacements have well functioning hips and are at a low risk of developing any serious problems. Patients with metal-on-metal hip replacements should already be regularly monitored by their clinician. “Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely. “We have previously taken prompt action in February to investigate safety concerns and provided advice on patient management to relevant healthcare professionals."  http://www.mhra.gov.uk/PrintPreview/PressReleaseSP/CON149601 For further information  Medical Device Alert: Metal-on-metal (MoM) total hip replacements (MDA/2012/016)  http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149600  http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con149604.pdf  Canada – Health Canada: Medical Device Recall Listings Date April 2012 – June 2012  Medical Device Recall Listings – Sorted by Recall Posting Date April 2012 – June 2012  Manufacturer –4 april 2012: Coloplast A/S, Abbott Point of Care Inc., Alere San Diego, Inc., Animas Corporation, Baxter Healthcare Corporation Renal Division, Becton Dickinson and Company, Brainlab AG, Carl Zeiss Meditec AG, Codman and Shurtleff Inc., GE Hangwei Medical Systems Co. Ltd., GE Healthcare Finland OY, Immucor Inc., Oxoid Company, Sorin Group Deutschland GMBH, Stryker Orthopeadics, Supersonic Imagine, Terumo Cardiovascular Systems Corp., Thoratec Corporation, Vascutek Ltd., ,  http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php  http://www.hc-sc.gc.ca/dhp-mps/alt_formats/xls/compli-conform/recall-retrait/list/md-im_recalls-retrait_apr-june_2012-eng.xls  Canada – Health Canada: Revisions made to guidance documents and forms for medical devices –fees  “Drugs and Health Products – What's New”  Revisions made to guidance documents and forms for drugs and medical devices to show the annual 2% increase in fees as per the Fees in Respect of Drugs and Medical Devices Regulations as well as other minor revisions to improve clarity of the Guidance Document – Fees for the Review of Drug Submissions and Applications.  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/cr_notice_rc_avis-eng.php  Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_licren_mm_homren-eng.php  Fees for the Review of Medical Device Licence Applications [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php  Class IV Medical Device Licence Amendment Application Form – Address Update [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php  Class III Medical Device Licence Amendment Application Form – Address Update [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php  Application For a New Class IV Medical Device Licence – Update [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php  Application For a New Class III Medical Device Licence – Update [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php  Application For a New Class II Medical Device Licence – Updated [2012-04-02]  http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php
  17. 17. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 11 April 2012 LEGIPH@RM International© March 30, 2012  Australia – Medical technology association of australia (MTAA): Medical technology industry a key to economic growth in Australia  2012 Media Releases – Medical technology industry a key to economic growth in Australia – 30 March 2012  Text: The medical technology industry is a highly innovative sector with the capability to create highskilled manufacturing jobs and to harness Australia’s strengths in health and medical research according to a white paper released by the Medical Technology Association of Australia (MTAA). The medical technology industry is largely overshadowed in the current debate about the contribution of the advanced manufacturing sector to Australia’s economic future but provides some leading examples of successful Australian manufacturing. “Australia has many of the right attributes to grow a strong domestic industry – a significant health and medical research capability, quality health system, highly skilled manufacturing workforce, stable financial system, and access to the growing middle class markets of Asia,” said Anne Trimmer, MTAA Chief Executive Officer. The medical technology industry has grown steadily in recent years to record revenue of $8.02 billion in 2010-11. However Australia suffers a net deficit in trade with significantly more products imported than exported. In fact the value of exports has fallen over the past three years. MTAA is calling on the Federal Government to provide policy leadership so that the right levers can be put in place to develop a sustainable medical technology industry for the long term. Policy strategies that might be employed to grow this sector of the Australian economy include better integration between health systems needs and industry innovation and development; emphasis on science, maths and engineering education; encouragement of clusters of industry and research; and pathways to market for innovative technologies, both in Australia and regionally. “Governments in other advanced economies have identified the medical technology sector as a growth area ready for policy support. Australia must compete to ensure that its advanced manufacturing sector retains a skilled workforce which can be used in medical technology manufacturing,” Ms Trimmer said.  http://www.mtaa.org.au/pages/page421.asp For further information  “The white paper Building a sustainable Australian medical technology industry – March 2012”  http://www.mtaa.org.au/pages/images/Building%20a%20sustainable%20Australian%20medical%20technology%20industry%20white%20paper%20final%20March %202012.pdf  Executive summary: […] Australia suffers an imbalance in trade in medical technology with most of the technology used in Australia imported, and nearly all of the medical technology products manufactured in Australia exported. Australia has excelled in the development of niche products to supply the global market – Resmed’s devices to treat sleep disorders, Cochlear’s electronic hearing device, and Sirtex’s Sirsphere’s cancer treatment device. […] The medical technology industry has not had the attention that is needed from policy makers. […] This white paper proposes strategies which give guidance for the development of policies to ensure a sustainable industry into the future.  Proposals for action:[…] MTAA proposes that a roundtable be established to undertake an audit of Australia’s capabilities and preparedness to develop a medical technology sector, to identify the gaps that would work against the development, and identify solutions to bridge those gaps.[…]  Profile of the medical technology industry in Australia: […] Total revenue for the Australian medical technology industry in 2010-11 is calculated by MTAA at $8.02 billion. […] Of the medical technology companies operating in Australia, approximately 23% are manufacturers, 21% are subsidiaries of multinational companies, and the remainder are independent distributors. […]  An innovative industry and emerging trends: […] Five new pillars of innovation will be required for the medical technology ecosystem in 2020: “System- oriented and value-based incentives (with a focus on the development of whole-care, patient-centred solutions)”, “Global networks of academic medical centres (noting the increasing investment by emerging nations in research and development)”, “Competing regulatory systems (companies will move into markets where they can obtain approvals more quickly, generate returns faster and engage patients and providers in the cycle of innovation)”, “Individualized solutions and price- sensitive customers (providers will look to companies worldwide for technology solutions that offer more integrated, holistic, cost-effective devices combined with wellness and disease management services)”, “Global financial networks (funding will follow the shift of investment opportunities to new markets)” […]  Need for policy levers: […] MTAA argues that as a nation we need to shift our focus to growth sectors such as the medical technology industry by providing incentives for companies to invest in additional research and development and local manufacturing much in the way that John Button’s plans for the pharmaceutical industry were structured in the 1980s when he was the Minister for Industry.[…]  What other countries are doing: Information on Singapore, South Korea, Ireland, Denmark and Israel  Deriving benefit from Australia’s proximity to Asia: […] There is an opportunity for innovative Australian companies to respond to the need of many Asian countries for more frugal technology which is suitable for low resource settings. […]  Building the manufacturing base: Information on Southeast Michigan Council of Governments and the Metropolitan UK and Australia
  18. 18. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 12 April 2012 LEGIPH@RM International©  Securing a skilled workforce: […] Where Australian companies are not able to recruit sufficient numbers of skilled workers locally, the retention of schemes such as the living away from home allowance assists in ensuring that appropriately skilled workers are attracted to Australia as a place to work, and their employers supported […]  Development of industry clusters: […] The medical technology sector would benefit from the nurturing of clusters which provide a well-established pathway for industry development in other countries. […] Information on Denmark, Sweden, Switzerland, Singapore, Korea, India and China  Supporting emerging companies: […] there is a need to support the development of prototype products at the critical early commercialisation stage […] Areas of assistance should be designed to ensure companies are well versed in regulatory affairs, quality management, and reimbursement and that they have access to clinical investigations and access to local manufacturing. Information on US and Canada  Regulatory alignment: […] The regulation of medical technology in Australia must remain aligned with major competitor economies. […] The number of clinical trials of medical technologies in Australia has also increased exponentially from around 10 in 2001 to around 340 in 2010 […] )  Integration with health policy: […] T here are excellent examples in comparable economies where health policy makers work with the medical technology industry and industry policy makers to put in place levers which support development of a sustainable industry.[…] governments in the United Kingdom over the past decade have instituted a range of policies to support the life sciences industry in that country […] In Canada, the Ontario Government announced the establishment in December 2011 of the MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE). […]  http://www.mtaa.org.au/pages/images/Building%20a%20sustainable%20Australian%20medical%20technology%20industry%20white%20paper%20final%20March %202012.pdf  Australia – Therapeutic goods administration (TGA): PIP breast implants – Information update  30 March 2012 – PIP breast implants – TGA update – Updated information on safety concerns with PIP breast implants  Text: […] Testing undertaken by TGA to date has not found evidence that the risks involved with the use of PIP breast implants are any greater than those for any other brand of silicone gel-filled breast implants. […] The Australian Government's advice remains that removal of PIP breast implants in the absence of evidence of rupture is not routinely required. […]  Reports of problems with PIP breast implants. The table below shows the number of instances of ruptured PIP breast implants notified to the TGA as of 29 March 2012. Reporter Confirmedi ruptures Unconfirmed ruptures surgeons 131 24 patients 54 7 supplier 24 0 All reporters 209 31  The TGA categorises ruptures as 'confirmed' if there is sufficient information to uniquely identify: (a)the patient, (b)the implant used, (c) that an X-Ray or other diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed. The TGA has sought further information but as yet has not received sufficient information to uniquely identify the rupture.  http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120330.htm  US – Food and Drug Administration (FDA): The safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems  Food and Drug Administration – Docket No. FDA-2012-N-0293 – Orthopaedic and Rehabilitation Devices Panel of the Medical – Devices Advisory Committee; Meeting  Summary: Announcement of a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA) to discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. The meeting will be open to the public. The meeting will be held on June 27 and 28, 2012, from 8 a.m. to 7 p.m. […]  http://www.gpo.gov/fdsys/pkg/FR-2012-03-30/html/2012-7767.htm
  19. 19. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 13 April 2012 LEGIPH@RM International© Supplementary information  Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. There are two categories of metal-on-metal hip arthroplasty systems: 1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions: a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia; b. Inflammatory degenerative joint disease such as rheumatoid arthritis; c. Correction of functional deformity; and, d. Revision procedures where other treatments or devices have failed. 2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or b. Inflammatory arthritis such as rheumatoid arthritis.  Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.  In February 2011, FDA published a Web site on MoM total and resurfacing hip systems with information for orthopedic surgeons and for patients with or considering hip replacement  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm).  Numerous recent publications, studies and registry reports have raised safety concerns for MoM THRs. In February 2012, the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published a Medical Device Alert with updated advice on the management and monitoring of patients implanted with MoM hip systems recommending more aggressive followup of patients with larger THR systems (>=36 millimeter (mm)).  Further information about actions taken by MHRA, with links to information about MoM hip implants for patients and healthcare professionals, is available on their Web site at  http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product- specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm.  In December 2011, the American Academy of Orthopedic Surgeons (AAOS) published an overview on MoM hip systems (total and resurfacing)(Ref. 1). The AAOS overview provides a summary of clinical outcomes in patients with MoM hip systems in comparison to other bearing surface combinations, addresses patient, implant and surgical factors that may predict successful/unsuccessful outcomes of MoM hip systems and discusses the prevalence of adverse clinical problems from MoM hip systems in comparison to other bearing surface combinations. One item referenced in the report is the Australian registry, which reported higher revision rates for patients with implants that have large- diameter heads (>=28 mm).  http://www.aaos.org/research/overviews/Metal_On_Metal.pdf.  While current data are highly suggestive that a large percentage of patients with MoM hip systems have successful outcomes, a recent scientific publication raised serious concerns about the failure rates of MoM hip systems for the UK population (Ref. 3). This peer-reviewed journal article presented the following findings regarding primary MoM THR: (1) Increased failure rate at 5 years for MoM THR related to larger head sizes; (2) significantly higher risk for revision in female patients (Note: In the United States, labeling discourages use of MoM hips in females of child bearing age with warnings in MoM THR labeling and contraindications in MoM hip resurfacing labeling); and (3) revisions for dislocation in men with MoM replacements were slightly lower, showing some benefit to larger head sizes.  http://www.thelancet.com/journals/lancet/article/PIIS0140-6736 (Ref.3) (broken link after publishing)  The committee will be asked to discuss the following as it pertains to these devices in the U.S. population: Device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical followup considerations for patients with MoM hip systems (total and resurfacing)[…]
  20. 20. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 14 April 2012 LEGIPH@RM International©  Japan – Ministry of health: Regenerative products and medical devices  Project – promotion of commercialization of regenerative products -medical devices, pharmaceuticals  http://www.mhlw.go.jp/stf/houdou/2r98520000026xxr.html  United-Kingdom – MHRA: Weekly list of Field Safety Notices 26 – 30 March 2012  Weekly list of Field Safety Notices 26 – 30 March 2012  Agfa Healthcare: X-ray, digital acquisition systems; direct digital radiography. DX-D 10G, DX-D 10C, DX-D 20G & DX-D 20C - digital detectors (connected via cable) for direct digital imaging size 35*43cm.  Boston Scientific: Urinary catheters and accessories - urinary tract access catheter. Imager™ II Urology Torque catheters.  Boston Scientific: Vascular cannula and catheters; catheter angiography. IMAGER™ II angiographic catheter.  Codman & Shurtleff: Implants, active, infusion pumps programmable pump. MEDSTREAM pump.  GBUK Healthcare: Suction equipment, suction catheter. TenderTip closed suction - TT02-12-T34-N, TT02-12-E54-N, TT02-14-T34-N, TT02-14-E54-N, TT03-12- T34-N, TT03-12-E54-N, TT03-14-T34-N, TT03-14-E54-N.  Meditech Systems: Breathing system components catheter mount. 22X150S X-tendable catheter mount + elbow.  Merck Serono: Injection devices - auto injector. Easypod.  Philips Healthcare: Computed tomography system. Brilliance 64 and Ingenuity CT with software version 3.5.1.  Philips Medical Systems: X-ray, fluoroscopy systems. MultiDiagnost Eleva FD.  Welch Allyn: Monitors, patient; multi parameter monitor. VSM 200 & 300 series, SPOT vital signs and SPOT LXi.  Wescott Medical: Urinary catheters and accessories - irrigation set. WEFLOW3.  http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146834 March 29, 2012  International – International Organisation for Standardisation: An ISO/IEC guide upgrades safety aspects in medical device standards  Geneva, Switzerland, 2012-02-29 – IEC and ISO have just published a new, improved guide to help standards writers address safety aspects in medical device standards even more thoroughly.  ISO/IEC Guide 63, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 1999 edition.  A global approach among manufacturers, users, regulatory authorities and other stakeholders is needed for the planning and development of medical device safety standards. To create a coherent approach to the treatment of safety in the preparation of standards, close coordination within and among committees responsible for different medical devices is necessary.  ISO/IEC Guide 63 is designed to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make optimal use of resources by only developing medical device safety standards for which there is a clear market requirement.  The guide is intended to be used by all ISO and IEC bodies involved in the development of medical device safety standards. It can also be used by non-ISO and IEC standards development organizations at the international, regional or national levels that are considering or are in the process of developing medical device safety standards and/or comparable documents.  http://www.iec.ch/newslog/2012/nr0212.htm
  21. 21. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 15 April 2012 LEGIPH@RM International©  Ireland parliament: PIP breast implants and the the revision of the medical devices legislation  Irish medicines board – oireachtas committee on health –poly implant prothèse (pip) breast implants  […] The revision of the medical devices legislation: The three primary European Directives relating to medical devices are being substantially revised by the European Commission and it is expected that they will adopt two new Regulations relating to medical devices before the end of July 2012. These will then be subject to debate at the European Council and Parliament. In early February 2012, Commissioner Dalli (Health & Consumers) has written to each of the national Ministers for Health across Europe indicating the need to increase control on medical devices to provide an appropriate level of protection to European citizen and restore trust and confidence in the regulatory system for devices. Commissioner Dalli recognised that legislative revision would take several years to come into effect and identified the need to act immediately to achieve these objectives.  Closing remarks: The IMB fully appreciates the anxiety and concern this issue has caused the 1,550 women affected in Ireland. We have been speaking individually with many women who have contacted us and have met with a group of representatives. We are ensuring that they have all the available information on this issue and are assisting them with their individual concerns. We have also been invited to attend meetings arranged by the Department of Health and the Chief Medical Officer with some of the cosmetic clinics and have added our voice to urging the clinics to have a duty of care to all their patients and to ensuring that all patients receive appropriate review. The advice of the IMB, based on the evidence available from the ongoing investigation, remains unchanged: there is no current evidence of particular health risks associated with PIP silicone breast implants. The IMB continues to advise women with these implants, that if they have any concerns about their breasts or implants, they should seek clinical advice from their implanting surgeon. The best interests of the affected women is our primary concern and we are monitoring the situation rigorously and liaising closely with our European and international regulatory colleagues to ensure that any new information that may emerge is assessed swiftly and that we continue to provide expert advice to the patients and indeed the cosmetic clinics involved.  http://www.oireachtas.ie/parliament/media/committees/healthandchildren/J39_OpeningStatement_FINAL.pdf  United Kingdom – Health and Safety Executive (HSE) / Medicines and Healthcare Products Regulatory Agency (MHRA): Arrangements for liaison between the HSE and the MHRA, Medical Devices Division  Arrangements for liaison between the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA), Medical Devices Division  http://www.hse.gov.uk/aboutus/howwework/framework/mhra-working-arrangements-agreement.doc Reminder:  The MHRA is an executive agency of the Department of Health with responsibility for ensuring that medicines and medical devices are effective and acceptably safe.  The HSE is responsible for the enforcement of the Health and Safety at Work etc Act 1974 throughout Great Britain. Its work includes ensuring that ‘risks to people’s health and safety from work activities are properly controlled’. Supplementary information about arrangements for liaison between the HSE and the MHRA  Foreword: The aim of this agreement is to describe and promote effective working arrangements between the Health and Safety Executive (HSE) and the Medical Devices Division of the Medicines and Healthcare products Regulatory Agency (MHRA). This agreement does not cover the Medicines Division of the MHRA. Good working relationships are particularly important with investigation and enforcement activity - to enable serious incidents to be investigated efficiently and with pace. We are making progress in this regard, with the MHRA recently becoming a signatory to the Work Related Deaths Protocol (WRDP) for England and Wales. Discussions are currently taking place with the MHRA on signing up to the Scottish WRDP. The HSE and the MHRA have a clear common interest in patient safety. This agreement sets out the commitment of the two organisations to work together effectively on matters concerning medical devices. In particular: co-operating on non-fatal accident investigations; investigating fatal accidents in accordance with the two WRDPs; sharing information; and raising awareness. This agreement is a living document and will be reviewed on a regular basis.  Excerpts: […] The HSE will inform the MHRA, as soon as practicable, when it becomes clear that information, or emerging evidence from an incident or a complaint, is relevant to the MHRA. This includes significant dangerous occurrences such as ones that might have resulted in major injury or death. […] MHRA staff will inform HSE as soon as practicable if they are notified of an incident involving the use of a medical device in relation to a work activity which has led to major injury or death. HSE and MHRA staff are aware of relevant contact details. […]
  22. 22. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 16 April 2012 LEGIPH@RM International©  Europe - Official Journal of the European Union: Regulation on electronic instructions for use of medical devices  Official Journal of the European Union 10.3.2012  COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF March 28, 2012  United-Kingdom – parliament Health Committee: All providers should offer to replace breast implants which have failed according to Health Committee  All providers should offer to replace breast implants which have failed according to Health Committee  The Health Committee welcomes the Government's decision to commission two reviews following public concern about breast implant surgery, following the decision of the French authorities to recommend removal of implants sourced from PIP.  The Committee recommends that Earl Howe's review should focus on the following key policy issues: The Committee is concerned about the quality of information available about devices that have been implanted into patients; the Committee regards the maintenance of a full audit trail of devices implanted into patients as essential to good medical practice, and recommends that these procedures should apply in all care environments – in both the public and private sector – and that the information should be readily retrievable by a patient's clinicians. The Committee was concerned by evidence that MRHA notices withdrawing CE registration from individual products do not require any positive response from non-NHS users of those products; it recommends that Earl Howe's Review consider requiring all relevant care providers to confirm they have received and acted on such notices. The Committee also recommends that such obligations should apply equally to all care providers – both public and private sector. The Committee was concerned by evidence that some patients may have received implants without being fully aware of the medium and long term consequences of such implantation – in particular including the fact that all implants eventually require replacement. Surgeons working in this field have a professional obligation to ensure that their patients consent to treatment and that such consent is provided on a fully informed basis. The Committee further recommends that the GMC review surgeons' performance of this obligation, and of the obligation to report adverse incidents concerning medical devices to the MHRA.  http://www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/news/12-03-22-pipreport/  United-Kingdom – Parliament: PIP Breast Implants and regulation of cosmetic interventions  Health Committee – Sixteenth Report –PIP Breast Implants and regulation of cosmetic interventions  Contents: […] “Evidence on the risks of PIP implants”, “Actions of the Department of Health and the MHRA”, “Regulatory issues” (“CE Mark”, “Register of implants”, “Responsibilities of provider organisations and medical professionals”, “Adverse incident reporting”, “Informed consent”, “Insurance”), “Conclusions and recommendations” […]  Tuesday 7 February 2012: Professor Sir Bruce Keogh KBE, NHS Medical Director, Professor Sir Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency, Dr Anne-Marie Slowther, Associate Professor of Clinical Ethics at Warwick Medical School and Consultant Clinical Ethicist at University Hospitals, Coventry and Warwickshire NHS Trust, and Mr Simon Withey, Consultant Plastic Surgeon, Member of the Council of the British Association of Aesthetic Plastic Surgeons and Member of the Steering Committee looking at Standards in Aesthetic Plastic Surgery.  http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1816/181602.htm For further information PIP Breast Implants and regulation of cosmetic interventions – Health Committee – 4 Regulatory issues  Procedures for the follow-up of the CE mark certification have been shown to be inadequate by what has happened in this case. Sir Bruce's review should examine how to strengthen the CE mark system—for example by ensuring that certified devices are subject to routine review. There must be a procedure whereby the concerns of national regulators regarding implants manufactured in another European country can be acted upon and investigated.
  23. 23. LEGIPHARM International - International Medical Devices Regulatory NEWS-IN-BRIEF – The relevance of information© IMDRNIB, 2012/05/N001 Page 17 April 2012 LEGIPH@RM International©  Sir Bruce's review should pursue the creation of a register of implants, to improve reporting of adverse incidents, allow better monitoring of outcomes, and allow swift communication with affected parties in the event of a problem being found. Inclusion on the register should be compulsory.  In the light of these issues, the Committee believes that these events prompt some serious concerns which need to be addressed both by provider organisations and the medical profession, and by their professional regulators.  http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1816/181608.htm  US – Food and Drug Administration (FDA): ISO 13485:2003 Voluntary Audit Report Submission Pilot Program  ISO 13485:2003 Voluntary Audit Report Submission Pilot Program  Online Video Presentation (with Captioning) – Printable Slide Presentation –Transcript  http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#gi  US – Food and Drug Administration (FDA): New FDA guidance on considerations used in device approval, de novo decisions – Clinical data, risks, benefits and patient risk tolerance outlined in process  New FDA guidance on considerations used in device approval, de novo decisions – Clinical data, risks, benefits and patient risk tolerance outlined in process  The U.S. Food and Drug Administration published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf FDA news release  Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The de novo process is available for low – and moderate – risk devices that have been found not substantially equivalent (NSE) to existing devices. When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations.  The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.The guidance: outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low – to moderate – risk devices describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device. “This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).  The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions. “In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297411.htm Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications – Table of Contents  The Statutory Standard for Safety and Effectiveness  Types of Scientific Evidence

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