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Changing medical device regulations in Europe and the U.S.

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Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.

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Changing medical device regulations in Europe and the U.S.

  1. 1. Changing Regulations in the EU and US 19th April 2016 London, UK
  2. 2. Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33 ©2016 Maetrics. All Rights Reserved. 2 Presentation Topics
  3. 3. ©2016 Maetrics. All Rights Reserved. 3 Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33 Presentation Topics
  4. 4. 4 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.
  5. 5. 5 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.
  6. 6. 6 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.
  7. 7. 7 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
  8. 8. 8 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.
  9. 9. 9 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.
  10. 10. 10 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.
  11. 11. 11 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.
  12. 12. ©2016 Maetrics. All Rights Reserved. 12 Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33 Presentation Topics
  13. 13. ©2016 Maetrics. All Rights Reserved. 13 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
  14. 14. ©2016 Maetrics. All Rights Reserved. 14 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
  15. 15. ©2016 Maetrics. All Rights Reserved. 15 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
  16. 16. ©2016 Maetrics. All Rights Reserved. 16 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
  17. 17. ©2016 Maetrics. All Rights Reserved. 17 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)
  18. 18. ©2016 Maetrics. All Rights Reserved. 18 Presentation Topics Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33
  19. 19. ©2016 Maetrics. All Rights Reserved. 19 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
  20. 20. ©2016 Maetrics. All Rights Reserved. 20 Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33 Presentation Topics
  21. 21. ©2016 Maetrics. All Rights Reserved. 21 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
  22. 22. ©2016 Maetrics. All Rights Reserved. 22 Presentation Topics Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33
  23. 23. 23 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
  24. 24. 24 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
  25. 25. 25 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
  26. 26. 26 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
  27. 27. ©2016 Maetrics. All Rights Reserved. 27 Presentation Topics Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33
  28. 28. 28 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
  29. 29. 29 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
  30. 30. ©2016 Maetrics. All Rights Reserved. 30 Presentation Topics Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33
  31. 31. 31 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
  32. 32. ©2016 Maetrics. All Rights Reserved. 32 Presentation Topics Introduction 3 Timelines 13 Reclassification 19 Reprocessing of Single Use Devices 21 Unique Device Identification (UDI) 23 Clinical Evidence 28 The Cost of Compliance 31 Questions 33
  33. 33. 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. 33 Contacts
  34. 34. Thank You! 34 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.

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