Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

The ROI of Good Quality & Compliance

879 views

Published on

A comprehensive look at a series of presentations on quality and compliance, recently presented in partnership with the ABHI in London.

  • Be the first to comment

  • Be the first to like this

The ROI of Good Quality & Compliance

  1. 1. The ROI of Good  Quality & Compliance April 19, 2016
  2. 2. 2 2015 Expanded service  offering and  geographical coverage Changing Regulations in EU & US for Medical Devices  Peter Rose, Managing Director Europe, Maetrics Introduction to the Proposed EU Medical Device Regulations Martin Penver, Head of Notified Body, LRQA Integrating Quality with Corporate Compliance to Provide the Greatest Return Seth Whitelaw, President & CEO, Whitelaw Compliance Group The Impact of a Good Quality Management System  Carl Dover, Vice President – Quality Strategy & Process Improvement, DePuy Synthes The Most Costly Problems and Why Continually Repeated  Adrian Toutoungi, Commercial Partner, Eversheds Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  3. 3. 3 2015 Expanded service  offering and  geographical coverageChanging Regulations in EU & US  for Medical Devices Peter Rose Managing Director Europe Maetrics Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  4. 4. Changing Regulations in  the EU and US 19th April 2016 London, UK
  5. 5. Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32 ©2016 Maetrics.  All Rights Reserved. 5 Presentation Topics
  6. 6. ©2016 Maetrics.  All Rights Reserved. 6 Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32 Presentation Topics
  7. 7. 7 Introduction  The most important change to the regulation of medical devices since CE marking was first  introduced  Much is the same, or clarified  Many important changes  The new MDR is not news:  First mooted as a Recast of the directive prior to 2007/47/EC  Process became politicised following high profile adverse publicity for the industry  PIP fraud using non‐medical grade silicone, over a 16 year period  MoM hip implants, vigilance failures  Pelvic floor mesh issues  Inconsistencies across Notified Bodies  Modernise the CE marking legislation   Improve patient safety  Assisting innovation and trade across the EU MDR Background ©2016 Maetrics.  All Rights Reserved.
  8. 8. 8 Introduction  The future is now  The future has already started  Unannounced Inspections  Clinical Evaluation Reports  Joint audits of Notified Bodies by DA, CAs and FVO  Reassessment of NBs by CA  Other key topics  Notified Body Capacity  EN ISO 13485:2016  OBL (on‐site QMS audit; TF, Unannounced Inspections at OEM, no chains of OBL)  Changes to EUAR liabilities, need for QP  Compulsory Liability Insurance for Manufacturers  Surveillance Fees in the UK  Apprentice Levy (0.5% >250 employees)  REACH / SVHC (168 substances limit to 0.1% w/w, at component level) Not just changes within the MDR ©2016 Maetrics.  All Rights Reserved.
  9. 9. 9 Introduction  The best companies will act early  Notified Body capacity should be a major concern   Wise to start planning now  Nothing much will change, but anything can   Learn the lessons from 2007/47/EC Book early to avoid disappointment ©2016 Maetrics.  All Rights Reserved.
  10. 10. 10 Introduction  2015 Data  2082 company inspections  Of whom, 797 companies received one or more 483s (38%)  Totaling 1008 individual 483s  Leading to 95 Warning Letters (4.5%)  This is NOT probability it depends on your state of compliance  Top 483 citations US – Compliance Trends ©2016 Maetrics.  All Rights Reserved. Year #1 #2 #3 #4 #5 2015 CAPA Complaint Files Purchasing  Controls Process Validation MDR 2014 CAPA Complaint Files Design  Controls Purchasing Controls Receiving, In‐Process,  Finished Device Acceptance 2013 CAPA Complaint Files Design  Controls Receiving, In‐Process,  Finished Device Acceptance Purchasing Controls
  11. 11. 11 Introduction  FDA have plans to change from the current 25 district and regional offices managing  inspections to 3 offices for worldwide  FDA have ‘Program Alignment Medical Devices and Radiological Health FY2016 Action Plan’  – see also http://www.fda.gov/AboutFDA/CentersOffices/ucm477082.htm A. Transition to Commodity‐Based and Vertically Integrated Regulatory Program (Specialization) B. Training and Certification C. Medical Devices and Radiological Health Program Work Planning D. Quality Policy and Strategy E. Imports F. Laboratory Optimization G. IT US Issues ©2016 Maetrics.  All Rights Reserved.
  12. 12. 12 Introduction  FDA are revising  CPGM – Compliance Program Guidance Manuals  IOM – Investigations Operations Manual  QSIT approach is under review with potential to be replaced by MDSAP (Medical Device Single  Audit Plan) and within that context FDA has already announced plans to retire the voluntary ISO  13485 program in favour of MDSAP. Note: this is not a commitment at this time. US Issues – Update of inspections Approach ©2016 Maetrics.  All Rights Reserved.
  13. 13. 13 Introduction A. Transition to Commodity‐Based and Vertically Integrated Regulatory Program (Specialization)  More focussed approach B. Training and Certification  Many more highly trained resources, currently most inspectors have very general knowledge C. Medical Devices and Radiological Health Program Work Planning  Prioritise resources in line with the plan, and enforcement priorities D. Quality Policy and Strategy  FDA looking for 90% of their staff to have some connection with the public over the next 2 years to  understand the patients perspective E. Imports  More enforcement action on imports, especially Indian drugs hot topic  Data integrity  Increased foreign inspections. Proposals for increased funding, and headcount F. Laboratory Optimization  LDT – laboratory developed testing, validation and robustness G. IT  Focus on data integrity, documentation systems validation, altering of data US Impact ©2016 Maetrics.  All Rights Reserved.
  14. 14. 14 Introduction  No longer at an advantage during occasions where inspectors lack knowledge  More and more Inspectors will be specialist and individually know more as a result of  extended training, e.g. electronics, software, 3D printing   Training from Industry means specialists will be able to keep up with new manufacturing  methods and materials  Efficiencies in filing times due to better skills set within FDA  Conversely, will also be quicker action on compliance side, e.g. warning letters currently take  months, anticipated to be much quicker US Impact ©2016 Maetrics.  All Rights Reserved.
  15. 15. ©2016 Maetrics.  All Rights Reserved. 15 Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32 Presentation Topics
  16. 16. ©2016 Maetrics.  All Rights Reserved. 16 Timelines  In the beginning  Final MDR expected to Enter into Force in Q2/2014  Always moving further away, but still ever closer  Latest expectations are Entry into Force will be around Q4/2016  Current status  5th October 2015 – Council agreed a full “General Approach”. Trilogues began with the Council,  Parliament and Commission  Luxembourgish presidency (July – December 2015)  – 5 Trilogues, progress slower than hoped  Dutch presidency (January – June 2016) – 3 Trilogues planned. Great expectations, for Q2/2016  Slovakian presidency (July – December 2016) – Q4/2016?  Malta presidency (January – June 2017)   United Kingdom presidency (July – December 2017) Timelines change frequently
  17. 17. ©2016 Maetrics.  All Rights Reserved. 17 Timelines MDR ‐ An early timeline 2012 2013 2014 2015 2016 2017 Draft MDR Sept 2012 Amendments  agreed Oct 2013 3 year transition period Entry into  force June 2014 Date of  Application  June 2017
  18. 18. ©2016 Maetrics.  All Rights Reserved. 18 Timelines MDR ‐ Current Timeline Estimate 2012 2013 2014 2015 2016 2017 Draft MDR Sept 2012 Amendments  agreed  Sept 2016? 3 year transition period Entry into  force Dec 2016? Date of  Application  Dec 2019? 2018 2019 2020 NBs can apply  +6 months for  re‐designation
  19. 19. ©2016 Maetrics.  All Rights Reserved. 19 Timelines  Entry into Force  The date the MDR is published in the OJ  The Date of Application  3 years after Entry into Force  6 months after Entry into Force, NBs may apply for Re‐designation under the MDR  Once granted NBs may begin to issue new certificates under the MDR and products may be legally  placed on the market under the new rules  UDAMED database – timing remains unclear  UDI requirements – timing remains unclear  Total of 43 delegated acts that need to be implemented before the entire MDR can be fully  implemented MDR ‐ Entry info Force & Date of Application
  20. 20. ©2016 Maetrics.  All Rights Reserved. 20 Timelines  The Date of Application is not necessarily the deadline  No requirement that devices must be re‐certified under the MDR by the Date Of Application of the  new Regulation   Transitional provisions  Certificates issued before to the entry into force of MDR stay valid for the period indicated on the  certificate ‒ Except certificates under Annex 4, Directive 90/385/EEC or Annex IV, Directive 93/42/EEC, which expire at the  latest 2 years after the Date Of Application   Certificates issued during the 3‐year transition period stay valid for the period indicated on the  certificate, BUT in any case will expire 4 years after the Date Of Application   Devices placed on the market under the current MDD before the Date Of Application may  be made available for up to 4 years after that date  MDR ‐ Certificate Validity (– but commercial pressures may apply)
  21. 21. ©2016 Maetrics.  All Rights Reserved. 21 Presentation Topics Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32
  22. 22. ©2016 Maetrics.  All Rights Reserved. 22 Reclassification  Classification rules are similar to before, but some significant examples of change:  In vitro contact with cells/embryos going back into the body to be Class III (or IIa)  Apheresis devices to be Class III  IVF and ART non‐invasive devices can be IIb  Spinal implants to be Class III  Total and partial joint replacements to be Class III  Devices recording diagnostic images to be IIa  Nanomaterial devices to be Class III  AIMD accessories to be Class III  Devices which are intended to be introduced into the human body via a body orifice, or applied on  skin and that are absorbed by or locally dispersed in the human body are to be Class III  Reusable surgical Instruments are no longer class I ‒ (CAUTION) Rumour about Class I with NB input Up‐Classification of Devices
  23. 23. ©2016 Maetrics.  All Rights Reserved. 23 Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32 Presentation Topics
  24. 24. ©2016 Maetrics.  All Rights Reserved. 24 Reprocessing of Single Use Devices   A sensitive subject for some, do these proposal enhance patient safety?  Still under debate   Allowed products list  Banned products list Default is that it is allowed and manufacturers must state why not (European  Parliament)  Re‐processers become legal manufacturers  Member States can control within their own borders  In‐house (i.e. hospitals) can continue to operate outside of the MDR  Re‐processers must confine activities to OEM once used product or their own re‐processed  products  Some debate over re‐processing vs fully refurbished Still Under Debate
  25. 25. ©2016 Maetrics.  All Rights Reserved. 25 Presentation Topics Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32
  26. 26. 26 Unique Device Identification (UDI) UDI System (Article 24) ©2016 Maetrics.  All Rights Reserved.  Article 24: A single system for UDI shall be put in place in the Union 1. Basic requirements for the UDI system  2. Issuing agencies for UDIs in Europe  3. Assignment of UDIs  4. Placing of UDIs on device labels / how UDIs should be used  5. Recording of UDIs  6. UDI database  7. Delegated acts related to running the UDI system  8. External factors 
  27. 27. 27 Unique Device Identification (UDI) Benefits of UDI ©2016 Maetrics.  All Rights Reserved.  To enhance the post‐market safety of medical devices by:   Improving incident reporting and recall processes  Increased visibility for competent authorities  Reducing the likelihood of product related errors  Better stock‐management by healthcare facilities  Counterfeit devices 
  28. 28. 28 Unique Device Identification (UDI) FDA ©2016 Maetrics.  All Rights Reserved.  UDI system – Final Rule 21 CFR Parts 16, 801 and 803  Published September 2013  Implements IMDRF UDI  Timetable according to classification
  29. 29. 29 Unique Device Identification (UDI) Its not just a bar code! ©2016 Maetrics.  All Rights Reserved.  Requirements to record, and verify, UDI information on  Complaints forms & records  Adverse Incident / MDR forms & records  Corrections & Removals forms & records  DHR including QC Release forms & records  Service forms & records  Should have been implemented in 2013  Unlikely to yield a 483 if UDI is not yet a requirement  Should include a UPC (Universal Product code) if no UDI   Includes UDI requirements as part of Design History
  30. 30. ©2016 Maetrics.  All Rights Reserved. 30 Presentation Topics Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32
  31. 31. 31 Clinical Evidence Requirements ©2016 Maetrics.  All Rights Reserved.  Chapter 6 (12 articles)  Clinical evaluation and clinical investigation  Annex XIII:  Clinical evaluation and PMCF  Annex XIV:  Clinical Investigations  Clinical evidence  Must justify the level of clinical evidence used (e.g. risk class, intended use, device characteristics, etc)  Performance is not equivalence  More data will be required, CERs already under greater scrutiny  Greater expectation that clinical investigations will be required, especially for Class III devices  Equivalence for Class III devices should not be from other manufacturers  Clinical investigations  Greater emphasis on patient safety   Data robustness and protection of patients during clinical investigations
  32. 32. 32 Clinical Evidence Data Sources ©2016 Maetrics.  All Rights Reserved. Rule 8 Clinical data  Clinical studies  PMCF  Scientific literature  Engagement with KOLs  Clinician and patient focus groups  Registries   Ongoing data sources  Active post market surveillance, routed through Risk Management process  Use error and feedback  Complaints, vigilance reports and MDRs  Ongoing research by legal manufacturer  Competitor data
  33. 33. ©2016 Maetrics.  All Rights Reserved. 33 Presentation Topics Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32
  34. 34. 34 The Cost of Compliance Its not going to get cheaper ©2016 Maetrics.  All Rights Reserved. Rule 8 MHRA surveillance fees  Notified Body fees, including unannounced visits  Punitive damages – regulators  Compensation and punitive damages – courts and patients / patient groups  Remediation projects  Increased requirements  CER  Risk  Up‐classification  New requirements  UDI  Person responsible for regulatory compliance  Professional assistance
  35. 35. ©2016 Maetrics.  All Rights Reserved. 35 Presentation Topics Introduction 3 Timelines 12 Reclassification 18 Reprocessing of Single Use Devices 20 Unique Device Identification (UDI) 22 Clinical Evidence 27 The Cost of Compliance 30 Questions 32
  36. 36. Maetrics Maetrics Ltd Peter Rose BioCity Nottingham Managing Director, Europe Pennyfoot Street prose@maetrics.com Nottingham +44 7811 199 346 NG1 1GF United Kingdom +44 115 921 6200 ©2016 Maetrics.  All Rights Reserved. 36 Contacts
  37. 37. 37 The contents of this presentation are copyright ©2016 Maetrics. All rights reserved. This presentation contains information in summary form and is intended for general  guidance only. It is not intended to be a substitute for detailed research or the exercise of  professional judgment. Maetrics cannot accept responsibility for loss occasioned to any  person, firm, company or corporation acting or refraining from action as a result of any  material in this publication. On any specific matter, reference should be made to the  appropriate professional advisor. ©2016 Maetrics.  All Rights Reserved.
  38. 38. 38 2015 Expanded service  offering and  geographical coverageIntroduction to the proposed EU  Medical Device Regulations Martin Penver Head of Notified Body LRQA Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  39. 39. Improving performance, reducing risk Introduction to the proposed EU Medical Device Regulations Martin Penver Head of Notified Body LRQA
  40. 40. NEW Medical Device Regulation – 26/09/2012 Currently Medical Device Directives (60 pages) Proposal are MDD & IVDD Regulations (278+) What is the difference (apart from 218 additional pages) ? Brussels, 26.9.2012, COM(2012) 542 final Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Directive is not enforceable by law across Europe, but can be adopted by each country Improving performance, reducing risk A caveat: Discussions and documents are based on the Council General Approach agreed in October 2015 – prior to negotiations with the Parliament and the Commission. The final text of the Medical Devices Regulation will differ from those underlying this discussion in various respects.
  41. 41. The political timetable – September 2015 Jan 2014 July 2014 Jan 2015 July 2015 Jan 2016 Greek Presidency Italian Presidency Rapporteurs appointed Luxembourg Presidency New Commissioners in place Latvian Presidency EP elections Council partial General Approach Trilogues commenced Conclude trilogues? Dutch Presidency Parliament 1st reading full General Approach Entry into force? July 2016 Slovak Presidency Started in 2012
  42. 42. The political timetable – March 2016 Jan 2014 July 2014 Jan 2015 July 2015 Jan 2016 Greek Presidency Italian Presidency Rapporteurs appointed Luxembourg Presidency New Commissioners in place Latvian Presidency EP elections Council partial General Approach Trilogues commenced Conclude trilogues? Dutch Presidency Parliament 1st reading full General Approach Entry into force? July 2016 Slovak Presidency Another 6 Months 6 Month delay
  43. 43. Trilogues - State of the negotiations • Council agreed a full ‘General Approach’ on 5 October 2015 – mandate for informal trilogue negotiations with European Parliament and Commission • 5 trilogues under the Luxembourgish Presidency – progress not as fast as hoped • Dutch Presidency (January-June 2016) – 3-4 political trilogues (17 Feb, 16 March, 7 April, ? May) – Informal political agreement by end of Dutch Presidency (June 2016?) – Slovak Presidency (July-December 2016) – Council formal First Reading Position (October 2016?) – Accelerated 2nd reading by EP and adoption of final Regulations (Autumn 2016?) Improving performance, reducing risk
  44. 44. Council text – Pre-market scrutiny • Expert Panels • Class III, implantable devices only • Notified Body retains final decision • Clinical Evaluation guidance & Common Specifications • Exemptions if NB judges conformity with the above, and for non- substantial modifications – LRQA – note some panels – NB abliged to use panel – may not need if similar products, may include renewals. This is only the council position, not yet definitive, expert panel will be available to manufacturers, could be 100’s of devices per year. – Panel will be a commission led process - Improving performance, reducing risk
  45. 45. Council text – In-house manufacturing exemption (IVD) • Largely positive inclusion but some concerns • Class C & D • Publication of in-house practices and justification • ‘Quality Management Systems’ • ‘Within health institutions’ – LRQA note: lists ISO15189 is stated or national provisions, some tests are not applicable to this standard. Large discussion “on an industrial scale” TERMINOLOGY – Reprocessing of single-use devices • Member State discretion • EU minimum standard – no less than in-house manufacturing, and reflect Common Specifications – LRQA note: this means re-CE marking required, plus CTS’s, some question on whether a NB is required Improving performance, reducing risk
  46. 46. Council text – Eudamed & unique device identification (UDI) – Single Registration Number (SRN) for economic operators – Manufacturers, Importers, Distributors required to store UDI – Healthcare institutions not required but some system needed Software – Not an active device – Classification concerns – CE marking Laboratory Information Management Systems (LIMS) LRQA note: Eudamed current design does not take into account UDI, so complete overhaul required, logic wrong. Improving performance, reducing risk
  47. 47. Council text – Clinical investigations – Coherence with Clinical Trials Regulation – Clinical evidence & equivalence LRQA note: “clinical” taken from IVD performance has been requested to be added back into the defined term. Has impact on ethics approval, to be brought up during technical discussions on technical regulation. – Post-market surveillance – Clearer requirements – Regular reporting for higher risk devices Classification rules – Further clarification during implementation LRQA note: 19 & 21 rules out class I, all surgical instruments will become class IIa. Improving performance, reducing risk
  48. 48. Council text Non-medical medical devices – Annex XV LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE DEFINITION OF ‘MEDICAL DEVICE’ REFERRED TO IN NUMBER (1) OF ARTICLE 2(1) 1. Contact lenses; 2. Implants for modification or fixation of body parts; 3. Facial or other dermal or mucous membrane fillers; 4. Equipment for liposuction; 5. Invasive laser equipment intended to be used on the human body; 6. Intense pulsed light equipment. Products can be continual added Common specifications as a trigger – What’s the problem here? (ER6) Cosmetic only - No medical benefit only risks Improving performance, reducing risk
  49. 49. Implementation - priorities • Pre-market scrutiny - Expert Panels • Re-processing – national law & guidance • In-house Manufacturing – guidance • Genomics & companion diagnostics – guidance • Software – guidance • UDI & Eudamed – IT system & guidance • Reference labs/expert panels – composition • Notified Body Operations Groups (NBOG) codes LRQA note:- more codes to be generated especially on IVD further discussions 3 year transition for MDD will it happen?  it will take 2 years just to re-designate at Notified bodies,  plus all the above.  Plus the Implementing / delegated acts (43 in total),  common specifications and guidance Improving performance, reducing risk
  50. 50. Lets go back to the current - Trilogues • Negotiations between European Parliament, Council and Commission So why since the Brussels, 26.9.2012 publication, has a final version not yet been agreed? • Politics? – Large differences still exist for scrutiny procedure and reprocessing of medical devices as well as the (compulsory) requirement for all manufacturers to have liability insurance (proposed by Parliament), which was rejected by Council. – The rapporteur for MDR - Glenis Willmott (S&D) - will be strongly bound in the coming months because of the referendum in the UK regarding the remaining in the EU. It is therefore questionable whether the planed timeframe can be adhered. – Maybe till June, there will be only a compromise regarding the main points of the Regulations. The details will then be regulated later on. • 3 versions of the MDR now exist • Immediate Actions following Dalli Stress Test (European Commission) The new regulation (920/2013) and recommendation (2013/473/EU which were published on the 24 September 2013 LRQA opinion is no immediate rush, and therefore the debate will continue Improving performance, reducing risk
  51. 51. Delegated and Implementing Acts MDR I = Implementing Act D = Delegated Act Relevance to NB : ++ very important, + important, o not so important Act Article Content Comm ission Parlia ment Counc il Relevan ce D 42 (11) - Conformity assessment procedures In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI. X ++In the light of technical and scientific progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI. X D 45 (5) - Certificates In the light of technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the minimum content of the certificates set out in Annex XII. X X X ++ D 89 (1) - Exercise of the delegation The Commission shall, in drafting delegated acts, seek the advice of the MDCG. X o I 94 (4) - Transitional provisions By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application if the relevant delegated acts and implementing acts have been implemented. X ++ *
  52. 52. Interpretation of text – will be difficult Lets look at one already implemented in Regulation 920 – 2013 All Nofitied Bodies shall – (a) the necessary administrative, technical, clinical and scientific personnel with technical and scientific knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data; The MHRA interpret this as A GMC registered & practising clinician, employed by the Notified Body Other Competent Authorities see this as having access to a medical person. Some of the Commission interpret this as Sufficient Clinicians to have specific knowledge of the full scope of devices that the Notified body certify, including Class III & AIMD products but also for ALL Class IIa & IIb medical devices. This includes the clinician peer reviewing all certificates already issued and re-check the clinical data. LRQA have asked for published guidance from the Commission – nothing yet. Published in 2013, with at least 3 interpretations, which affect the consistency of all notified bodies completing the same assessments and therefore the same reviews on clients across the world (Interpretation of 278 pages plus implementing and delegating acts) – not good for Manufacturers or Notified Bodies and will it make improve product performance and safety ?
  53. 53. Impact of Short Term Changes to the System Discovery of a 16 year fraud in PIP breast implants using low quality “industrial grade” silicon oil Stress test performed by EU Commission Determined that changes were needed to improve early detection and prevent this type of incident Other high profile vigilance cases with hips, pelvic floor meshes, pacemaker leads, etc. Outcome: short term changes to the system – Safety & Performance Immediate Actions – Commission Regulation: How Competent Authorities control Notified Bodies – Commission Recommendation: How Notified Bodies audit Manufacturers Improving performance, reducing risk
  54. 54. The new regulation (920/2013) and recommendation (2013/473/EU which were published on the 24 September 2013 MDR & IVDR Proposal Additional ENVI Proposals 920/2013 2013/473/EU Implemented Sept 2013 Improving performance, reducing risk
  55. 55. COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies – Re-assessment of qualifications and scope of activities of NBs – Joint Audits of NBs by Designating Authority, Commission (FVO) plus two other CA’s • NBs and Designating Authorities under scrutiny • Highlights different approaches in Member States • More scrutiny of competency requirements, in-house clinicians, qualifications: NBOG Codes. • Processes and procedures clarified IMPACT – 83 down to 61 (so far – not yet finished)
  56. 56. Impact of Com. Recommendation (2013/473/EU) on audits and assessments performed by NBs – Items to be verified by NB during an audit Improving performance, reducing risk – Annex III: Unannounced visits to manufacturers, "critical subcontractors" or “crucial suppliers”, in addition to planned audits • Completely new requirement needing extra product and QMS assessors • Significant increase in NB workload and resources • First 3 year cycle to be completed by March 2017 LRQA on-track and demonstrated this at our re-designation audit Sharing of UV’s for CS or CS – discussions ongoing with NB’s but 1 UV not sufficient
  57. 57. What is required within an unannounced visit (UV)? – Your Notified Body must have already communicated – Additional visit to normal LRQA assessments – not take less than one day and should be executed by at least two auditors – Sample devices belonging to at least three different device types – Verifying conformity of a recently produced adequate sample (product, batch, lot) of an approved device type – Traceability audit (device history record and reconciliation of stock) – Witness selected tests – sampling criteria and testing procedures should be identified in advance – Review two critical processes Improving performance, reducing risk
  58. 58. Annex II . 2 Critical subcontractors and crucial suppliers Critical – risk based approach by NB’s – Key processes may not be done at the main site, and may involve subsidiaries or OEM’s – LRQA needs to know who are the critical suppliers / subcontractors – LRQA use the logic provided by IVD working group
  59. 59. Experience gained from Un-announced Visits – Preparation is key, create a client pack for the assessment team, with an identification of what products are on our wish list. – Clients shock when auditors arrive – various reactions, key is to have the list of 4 or 5 contacts (if people are on vacation) – The team will need to categorize non-conformities into either (a) “Product” – may affect CE certificate –immediate action required (b) “QMS” – can be followed up at normal surveillance visit – Robust refusal policy required, 30 day resolution timescale before CE certificate is suspended – this is a product audit. Worst case is another PIP. Note: visit charged to client for refusal. So lose / lose scenario. One refusal so far by a critical subcontractor who does supply other major clients Two clients require additional visits as key processes done at “other sites” One certificate suspension after visiting a Critical Subcontractor – Clients are doing what they have always told us they were doing – no real surprises (except one). Improving performance, reducing risk
  60. 60. What is in the recommendation that is different/new? – OBL requirement for Technical files Recommendation 2013/473/EU, was issued to facilitate consistent application of conformity assessments contained within the Medical Directives. Page 2 of recommendation (9) Subcontractors or suppliers cannot fulfil in the manufacturers’ place crucial obligations of manufacturers, such as keeping available the full technical documentation, as this would void the concept of the manufacturer as responsible in accordance with Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC. Therefore, the notified bodies should be advised on what they need to verify in case of outsourcing. Page 3 of recommendation under Annex I – Product assessment 7. Notified bodies should verify all documentation related to the device’s conformity assessment. To that end, they should verify that the technical documentation is correct, consistent, relevant, up-to-date and complete ( 4 ) and that it covers all variants and trade names of the device. They should furthermore verify that the manufacturer’s device identification. ( (4) refers to a STED ) Improving performance, reducing risk
  61. 61. Meeting with the MHRA in February 2016 – The MHRA have provided all UK notified bodies with a guidance document covering own Brand Labelling. 1. OBL is not a term within the Medical Directive, there are only legal manufacturers – Clients are Virtual Manufacturers 2. Notified Bodies must complete an onsite QMS visit at an OBL company 3. Notified bodies must sample the FULL technical file. 4. MHRA are producing further Guidance in April 2016 5. OBL companies need to change their contracts with the OEM a. To allow full access to propriety information for the OBL’s Notified Body. b. To allow un-announced audits by the OBL notified body c. OEM should make a declaration that they manufacture the product and not outsource it to another OEM.
  62. 62. Experience gained from reviewing OBL technical file requirements – Why are you an OBL? Why not a distributor ? – MHRA have agreed to publish guidance on this – No NB costs & no un-announce visits Improving performance, reducing risk
  63. 63. MDR Proposals – 1 • Strengthened Designation Criteria • Joint Audits: Three Member States and Commission (FVO) • Unannounced Inspections Notified Bodies • Less Equivalence, More Data for High Risk Devices • Publish Safety and Performance Data • Post Market Clinical Follow-up Clinical Evidence • Scrutiny for High Risk Devices • Common Technical Specifications • Qualified Person for Manufacturers and Authorised Representatives Pre- market Improving performance, reducing risk
  64. 64. MDR Proposals – 2 • Central Database and Co-ordination • Trend Reporting • Enforcement Activities Post-Market Surveillance and Vigilance • Devices and Economic Operators Registered Centrally • Unique Device Identification (UDI) • Implant Cards Transparency and Traceability • Central Committees: Scientific Advice, Harmonised Implementation • Expert Panels • JRC, Reference Laboratories Governance and Oversight Improving performance, reducing risk
  65. 65. LRQA Conclusion – Where are the possible risks To Much Focus? – Duplication of visits on OEM’s Critical Subcontractors and Crucial subcontracts with multiple Notified Body un-announce visits with no additional benefit – does not add value, but is a requirement of the recommendation. Lack of Focus? – Mean while who is reviewing Class 1 non sterile or non Measuring? CA’s – no resource  ALL Manufacturers still need a Declaration of Conformity as per Annex VII of the MDD 93/42/EEC  Annex VII requires technical documentation (Instrument sets)(incontinence pads)  Annex VII requires conformance with Annex I (essential requirements) ( biocompatibility, state of the art, risk, clinical) Interpretation of text? – Clinician requirements are different – Un-announced visits – are all NB’s doing the same level? No CA witnessing (YET) – OBL will nearly become consistent 3 years after publication ( 1 member state still going to use OBL) Improving performance, reducing risk
  66. 66. Lloyd’s Register and variants of it are trading names of Lloyd’s Register Group Limited, its subsidiaries and affiliates. Copyright © Lloyd’s Register Quality Assurance Limited 2014. A member of the Lloyd’s Register group. Improving performance, reducing risk Martin Penver T 0800 783 2179 E enquiries@lrqa.co.uk W www.lrqa.co.uk/medical 1 Trinity Park, Bickenhill Lane, Birmingham, B37 7ES, United Kingdom Contact Us LRQA T +44 (0)330 4141244 E martin.penver@lrqa.com General Enquiries to Business Support staff T +44 (0)330 4141348 E medicaldirectives@lrqa.com
  67. 67. 67 2015 Expanded service  offering and  geographical coverageIntegrating Quality with Corporate Compliance to  Provide the Greatest Return Dr. Seth Whitelaw  President & CEO Whitelaw Compliance Group Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  68. 68. 1 is the Loneliest Number Integrating Quality & Corporate Compliance To Provide the Greatest Return Maetrics The ROI of Good  Quality &  Compliance  London April 19, 2016 Whitelaw Compliance Group, LLC.
  69. 69. Copyright © 2015 Whitelaw Compliance Group LLC. All rights reserved The “Heart of Darkness” 69 1‐Press Release by Senator Charles Grassley (February 1, 2013) 2‐Eric Campbell et al., A National Survey of Physician‐Industry Relationships, 356 N Engl. J. Med. 1742, 1746‐47 (2007) 3‐Martin Roland, et al., Professional values and reported behaviors of doctors in the USA and UK: quantitative survey, Brit. Med. J. Quality & Safety at 3 (2011),  http://qualitysafety.bmj.com/content/early/2011/02/07/bmjqs.2010.048173.full 4‐David Grande, et al., Pharmaceutical Industry Gifts to Physicians: Patient Beliefs and Trust in Physicians and the Health Care System, J. Gen. Intern. Med. (Jun. 14, 2011), available at  http://www.ncbi.nlm.nih.gov/pubmed/21671130 NEED FOR  TRANSPARENCY  Only 78.7% of U.S. physicians believe in putting a patient’s interest above their own.2  64% of surveyed physicians said that disclosure for doctors should be mandatory.3  83% supported mandatory disclosure for researchers.3 Physician Perspective  “We want our doctors … to rely on evidence that is real and true and accurate and not partial or affected some way by a money interest behind it.”1  “The case has clearly been made for requiring industry to report payments to physicians, especially those conducting highly influential research, often with taxpayer support. Operating with transparency sends a message that there’s nothing to hide.”2 Congressional Perspective  94% of U.S. physicians have had a relationship with a life sciences company2 Life Science Perspective  55% of patients believe their doctor receives industry gifts4 Patient Perspective
  70. 70. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Causing Pressure for Reform to Build  Intractable quality issues are dominating the global news  Indian API debacle  Chinese reform efforts  Price and quality are in the forefront of the U.S. election  Unsupported price increases  Value-based pricing 70
  71. 71. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Leading to Increased Enforcement 71 0 5000 10000 15000 20000 2008 2009 2010 2011 2012 2013 2014 2015 FDA Warning Letters Fiscal Years 2008 – 20151 0 500 1000 1500 2010 2011 2012 2013 2014 Federal Criminal Healthcare Fraud Prosecutions (FY10-FY14)2 1http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM384647.pdf 2HHS & DOJ Annual Reports on Healthcare Fraud and Abuse Control Program
  72. 72. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved While Regulators Struggle with Dated Frameworks  Off-label vs. 1st Amendment  Software as a medical device  Genetic testing and dietary supplements  Drug shortages  Opioid misuse 72
  73. 73. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Quality & Compliance Not Keeping Pace 73 CEO Chief Quality Officer Manufacturing Quality R&D Quality Chief Compliance Officer Compliance Operations
  74. 74. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved The Disconnect 74 External Regulations Internal Audits Quality Control Quality Assurance Quality Corporate Compliance
  75. 75. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved How It Needs to Work 75 CEO Chief Compliance Officer Compliance Operations Chief Quality Officer Manufacturing Quality R&D Quality
  76. 76. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Achieving An Integrated Team  Securing commitment  At all organizational levels  Establishing an agreed upon framework  Objectives of integrating  Speaking the same language  Defining the key terms (e.g., “risk”)  Identifying combined compliance/quality expertise 76
  77. 77. Copyright © 2015 Whitelaw Compliance Group LLC. All rights reserved It Isn’t Just Theory INVACARE, VALEANT AND OTHER NOTABLE STORIES 77
  78. 78. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Invacare  2012 Consent Decree  Last 3 years lost money  Latest Inspection (12/2015)  5 months duration  11 page FDA-483  Consent decree non-compliance  CEO asserting strong compliance culture is top priority 78
  79. 79. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Valeant  Virazole microbial contamination recall  Accusations of improper relationship with PBM Philidor to recommend Valeant drugs  Hedge fund loses >$1B in single day (3/15/16)  Former CEO subpoenaed to testify before Senate on drug pricing 79
  80. 80. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved OtisMed Corp.  Distributed product after FDA refused to approve their application.  Company acquired by Stryker.  Company paid more than $80 million dollars in civil and criminal fines.  Its CEO pled guilty to criminal charges, and was sentenced this year to serve 24 months in prison, 1 year supervised release and a $75,000 fine. 80
  81. 81. Copyright © 2016 Whitelaw Compliance Group LLC. All rights reserved Olympus Corporation of America  3 separate regulatory actions  FDA  Anti-kickback and False Claims Act violations  FCPA  3 separate regulatory outcomes  Warning Letters and Recalls  Corporate Integrity Agreement  Deferred Prosecution Agreement  Total settlement - $646 million  Chief Compliance Officer was the whistleblower 81
  82. 82. Copyright © 2015 Whitelaw Compliance Group LLC. All rights reserved Whitelaw Compliance Group, LLC. helping companies grow sustainable integrity www.WhitelawCompliance.com +1.215.275.1556 82
  83. 83. 83 2015 Expanded service  offering and  geographical coverageThe Impact of a Good  Quality Management System  Carl Dover Vice President – Quality Strategy & Process Improvement DePuy Synthes Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  84. 84. The ROI of Good Quality & Compliance The Impact of a Good Quality Management System Carl Dover Vice President, Quality Strategy & Process Improvement DePuy Synthes Maetrics Regulatory Seminar by ABHI: The ROI of Good Quality & Compliance 19th April 2016
  85. 85. The ROI of Good Quality & Compliance Quality Management Systems Development Quality is COMPLIANCE Quality is a DISCIPLINE Quality is an INTEGRATED CAPABILITY COMPETENCY Proactive Quality is a CORE COMPETENCY Proactive Quality is a DIFFERENTIATOR
  86. 86. The ROI of Good Quality & Compliance Quality is Compliance • The Starting Point • Foundational Systems • Market Access Opportunity Areas: • More Reactive than Proactive • Internal Complexity • Higher Cost of Quality • Internally Focused • Sustainability Issues
  87. 87. The ROI of Good Quality & Compliance Quality is a Discipline • > Compliance Outcomes • Enhanced Technical Capabilities • Capability Risk Reduction Focus • Reduced Cost of Non Conformance Opportunity Areas: • Goal Alignment • Governance • Speed to Market • External Focus • Customer Satisfaction
  88. 88. The ROI of Good Quality & Compliance Quality is an Integrated Capability • Reduced Complexity • Cross Functional Engagement • Organizational Capability • > Design, LEAN, QE Outcomes • Robust External Manufacturing • Faster Cycle Times • Reliable, Predictable Supply • Cost Of Quality Improvement Opportunity Areas: • Proactive Quality • Triple Aim • Field Action Trend • Quality Culture & Sustainability Cost of Non-Conformance Internal Failures External Failures Cost of Conformance PreventionAppraisal
  89. 89. The ROI of Good Quality & Compliance Proactive Quality : A Core Competency + Competitive Differentiator • Predictive Analytics • Reduced Complexity - Agile, Scalable, Integrated Quality Systems • Higher Investment in Prevention • Patient Centric Solutions – Triple Aim – Satisfaction/Outcomes/Costs • Higher Reinvestment in Breakthrough Innovation • Anticipating & Shaping the External Environment • Recognized Sustainable Culture of Quality Compliant, quality products & services Reliable supply of high quality products & services Innovative, high quality products & services through customer insights PROACTIVE QUALITY delivers BUSINESS GROWTH and CUSTOMER VALUE Cost of Quality measured COMPLIANT Achieve top quartile COQ benchmark INTEGRATED Reinvestment of cost savings in Innovation PROACTIVE
  90. 90. The ROI of Good Quality & Compliance Additional Benefits Cost of Quality Customer Satisfaction Consolidation Organizational Capability Guaranteed Supply EngagementIntegration Agility L&A
  91. 91. 91 2015 Expanded service  offering and  geographical coverageThe Most Costly Problems and Why Continually Repeated  Adrian Toutoungi Commercial Partner Eversheds Maetrics Regulatory Event in Collaboration with ABHI The ROI of Good Quality & Compliance
  92. 92. The most costly problems (and why continually repeated)? Adrian Toutoungi Partner - Eversheds LLP 19 April 2016
  93. 93. 1. Data privacy 2. Borderline issues 3. Unharmonized issues − advertising and promotion of medical devices − registration requirements − enforcement 4. Beyond regulatory compliance On the Agenda – Traps for the unwary
  94. 94. 1. Data Privacy
  95. 95. Eversheds LLP | 19/04/2016 | − An increasing problem for medical device manufacturers − Conventional devices − e-health (Internet of Things) − m-health Data privacy
  96. 96. Eversheds LLP | 19/04/2016 | − Local, variable implementation − Personal data • information which on its own on when combined with other information held, identifies or relates to a living individual − Processing • any use, including storing or reading − Sensitive personal data − Data Protection principles • fair and lawful use • security • export − Maximum fine in UK: £500,000 Data Protection Directive 95/46/EC The existing regime
  97. 97. Eversheds LLP | 19/04/2016 | − Direct effect from 2018 − More detailed rules and obligations − Privacy by design and default − Tightened rules • notice • consent • lawful use − Mandatory reporting of breaches − Enforcement • potential fines of up to 4% of global turnover General Data Protection Regulation The upcoming regime
  98. 98. Eversheds LLP | 19/04/2016 | − Medical imaging technology • MRI scanner • Database of scanned images • Access by device supplier • Impact on market launch? − m-Health software apps Examples
  99. 99. 2. Borderline issues
  100. 100. Eversheds LLP | 19/04/2016 | − Qualification of a product can be uncertain • medical device v medicinal product • medicinal product v cosmetic product • others − Increasingly sophisticated products • technical advances outpacing legislation and guidance • combination products (incorporate or designed to administer a medicinal product) − Qualification may be vital • commercial viability (cost, timing to market) • to gain a competitive advantage Borderline issues
  101. 101. Eversheds LLP | 19/04/2016 | − Article 1(2) of Directive 2001/83/EC • Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; • Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’. − Consider both presentation and function − Definition has evolved over the years Definition of medicinal product
  102. 102. any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means’ Definition of ‘Medical Device’, Article 1.2 of Directive 93/42/EEC
  103. 103. Eversheds LLP | 19/04/2016 | − Article 2(2) Directive 2001/83/EC • in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a medicinal product and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply” − Borderline MEDDEV − European Commission Manual on Borderline and Classification in the Community Regulatory Framework for Medical devices, Version 1.16 (07-2014) − Further guidance from national regulators • Guide to What is a Medicinal Product • MHRA Borderline Guidance A uniform approach?
  104. 104. Eversheds LLP | 19/04/2016 | - Gynocaps capsule • for correcting bacterial imbalances in the vagina • lactobacillus, lactose and magnesium stearate in a gelatine capsule • Marketed as a Class III device since 2006 in AU, DE, ES, FIN, FR • reclassified in FIN as a medicinal product in November 2008 - CJEU confirmed that MS are not bound by decisions of other MS - Major adverse commercial impact Laboratoires Lyocentre case (Case C-109/12,
  105. 105. Overview of different MS Member State Legal Framework Borderline Products Belgium Assessment of border products is carried out by a specific body in the Federal Agency for Medicines and Health Products (FAFMP) – the joint committee France Classification is carried out by French Agency of Sanitary Security of Health Products (AFSSaPS). Case law prefers a broad view of the term “medicinal product” Germany Extensive civil and administrative case law on classification of borderline products Italy The Italian Ministry of Health is the Competent Authority on borderline issues. It follows the borderline MEDDEV and Guidance The Netherlands Assessment is carried out by the CIBG Sweden There is some civil case law on classification of borderline products UK MHRA’s Borderline section offers advice. The MHRA also publishes its own guidance
  106. 106. − Review the applicable legislation and guidance − Check precedent cases and competent authority decisions − Consider the method by which the principal action is achieved − Consider the intended purpose of the product, taking into account the presentation • careful positioning of the product may be required • ensure consistency of labelling, claims and advertising − Consider limiting marketing of the product to selected MS − Don’t assume that the US classification will apply, or even be persuasive Practical tips on dealing with borderline questions
  107. 107. Eversheds LLP | 19/04/2016 | −Mouthwash • purpose of the product was to reduce bacterially-caused dental plaque and to protect from gingivitis • “pharmacological means” = interaction between molecules of the substance and a cellular constituent (usually referred to as a receptor) which either results in a direct response or blocks the response to another agent (borderline MEDDEV) • CJEU clarified that the cellular constituent must be present in the user’s body, but does not need to be a cellular constituent of the user’s body. −Hyaluronic acid and sodium pre-filled syringe • natural compound of joint fluid, which provides the viscosity and elasticity required for protection of joints • principal means of action was physical −Stand-alone software • a different type of borderline issue Examples
  108. 108. 3. Unharmonized issues
  109. 109. Eversheds LLP | 19/04/2016 | − Do not overestimate the degree of EU harmonization • take local law advice − Aim of New Approach • No further conformity assessments should be required • But Article 14 allows MS to require notification by manufacturer of marketing of Class IIa, IIb and III devices; • other issues are unharmonized (e.g. enforcement, transfers of value to HCP) − Advertising/promotion is not harmonized • Directive 2006/114/EC, concerning misleading and comparative advertising • Directive 2005/29/EC concerning unfair business-to-consumer commercial practices • Eucomed Code of Ethical Business Practice • National laws and guidance may be more stringent • Careful clearance of advertising campaigns is required Lack of regulatory harmonization across the EU
  110. 110. Eversheds LLP | 19/04/2016 | Member State Provisions relating to medical device marketing Belgium No advertising of non-CE marked devices (Royal Decree). Limited exemption for trade fairs, exhibitions and demonstrations France No specific regulation. French Consumer Code prohibits false or misleading advertising. Enforced by DGCCRF Germany Strict provisions on advertising medical devices can be found in the Law on Advertising of Medicinal Products. Also Code of Conduct of trade bodies Italy Advertising to general public of prescription devices or devices only used with the assistance of an HCP is prohibited; other advertising requires prior consent of Ministry of Health. Some regional regulations too, and provisions in the Assobiomedica Code of Conduct The Netherlands Few specific provisions. The self-regulatory Code on Public Advertising of Medical Devices 2009 applies. Medical device advertising is however subject to pre-approval by the council of Inspection of Public Advertising of Medicinal Products (KOAG) Spain FENIN Code of Conduct (Association of manufacturers of medical devices) regulates advertising of medical devices UK No specific regulation. ABHI Code of Conduct. Advertising medical devices in the EU regulation
  111. 111. 4. Beyond regulatory compliance
  112. 112. Eversheds LLP | 19/04/2016 | −Procurement • failing to challenge tender processes and unfavourable awards −Product liability • intended use, device description, instructions for the user −Pricing and reimbursement • failing to challenge unfavourable Health Technology Assessments − Patent infringement issues • Unified Patent Court and Unitary Patent A wider perspective on costly problems in the sector Beyond regulatory compliance
  113. 113. CAR_LIB1-#11019113
  114. 114. Europe 01 London 24 Turku 02 Ipswich 25 Helsinki 03 Cambridge 26 Tallinn 04 Cardiff 27 Riga 05 Birmingham 28 Vilnius 06 Nottingham 29 Warsaw 07 Manchester 30 Budapest 08 Leeds 31 Vienna 09 Newcastle 32 Munich 10 Edinburgh 33 Zurich 11 Dublin 34 Berne 12 Belfast 35 Geneva 13 Paris 36 Madrid 14 Brussels 37 Milan 15 Rotterdam 38 Rome 16 Amsterdam 39 Bucharest 17 Hamburg Africa18 Berlin 19 Stockholm 40 Tunis 20 Pori 41 Durban 21 Tampere 42 Johannesburg (Bryanston) 22 Jyvaskyla 43 Johannesburg (Sandton) 23 Hameenlinna 44 Port Louis Middle East 45 Amman 46 Erbil 47 Baghdad 48 Riyadh 49 Doha 50 Abu Dhabi 51 Dubai Asia 52 Beijing 53 Shanghai 54 Hong Kong 55 Singapore LDS_002-#4206473CAR_LIB1-#11019113CAM_1B-#4930708
  115. 115. eversheds.com ©2016 Eversheds LLP Eversheds LLP is a limited liability partnership Adrian Toutoungi Partner - Eversheds LLP +44 788 775 4482 adriantoutoungi@eversheds. com

×