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MDR and class I medical devices presentation

Presentation of how the EU Medical Devices Regulation affects class I medical devices

MDR and class I medical devices presentation

  1. 1. CLASS I AND MDR Erik Vollebregt www.axonadvocaten.nl
  2. 2. Agenda • Transition and Corrigendum • Who is upclassified? • The gap • Further developments
  3. 3. MDD class I to MDR class I MDD class I device MDR class I Now 26 May 2020 at the latest Step 1
  4. 4. The gap from MDD class I to MDR class I • New definitions that mess with scope and classification • New claims / advertising provisions • Article 10 and everything that flows from it must be implemented • New technical documentation plus risk management system • Large gaps • More Data Really / CE = Clinical Evidence • Closing the gap takes time: new clinical evaluations required • New PMS, PMCF, PMS reporting and vigilance reporting
  5. 5. The gap from MDD class I to MDR class I • New full QMS (ISO 13485:2016 plus - see TR 17223) • Very large gap if you come from Annex VII MDD • Economic operator rules • PRRC / AR • Systems and procedure pack rules • Sufficient coverage for liability • And all the rest
  6. 6. Who is up-classified from class I / needs a CE cert under MDR? Mostly • Rule 11 – software • Rule 19 – nanomaterials containing products • Rule 20 – inhalers • Rule 21 – substance based devices And of course the class I reusable surgical instruments
  7. 7. MDD class I two-step for upclassifieds MDD class I device MDR class I soft transition device MDR class IIa or higher device Now 26 May 2024 at the latest Step 1 Step 2
  8. 8. Breaking: corrigendum 2 • Still to be approved formally by member states and by European Parliament
  9. 9. Breaking: corrigendum 2
  10. 10. Breaking: corrigendum 2
  11. 11. Caution Corrigendum 2 • Corrigendum is not a done deal yet, even though it looks like it • Plenary Parliament still has to confirm 3 December ENVI vote • Class I m and s were already covered by article 120 (3) and (4) (MDR FAQ CAMD question 13)
  12. 12. Summary corrigendum • Devices that need a CE certificate under MDR but have a valid DoC before 26 May can ride out the DoC until 26 May 2024 • BUT: they may not make any significant changes in intended purpose or design • They will still need an MDR CE certificate as of 27 May 2024 • When these devices have been placed on the market before 26 May 2024, they may still be sold until 27 May 2025; after that date they cannot be sold anymore
  13. 13. What is a significant change? • Significant changes cannot be implemented until device has an MDR CE certificate • ‘Substantial change’ in NBOG guidance is not the same as a significant change in article 120 (3) MDR • Different interpretations circulate depending on notified body concerned • For class I devices only NCA interpretation relevant: MDCG to the rescue with interpretation of ‘significant change’?
  14. 14. What is not a significant change?
  15. 15. Monitoring of significant changes • No notified body to monitor significant changes • This means that competent authority can check on ex post basis • Class I manufacturer must be super vigilant not implement a change that is significant • Finding of significant change means immediate infringement of the MDR (placing product on the market without CE) • Super strong QMS needed
  16. 16. The gap to MDR class I in soft transition Application of MDR requirements in place of the corresponding requirements of the Directives with regard to: a) Registration of economic operators and of devices (see Art. 31 MDR and Art. 29 MDR) b) Post market surveillance (PMS) (see Art. 83-86, 92 MDR including Annex III but without the PMS having to be an integral part of the QMS) c) Market surveillance (see Art. 93 – 100 MDR, but device standards to be met = Directives) d) Vigilance (see Art- 87-92 MDR)
  17. 17. The gap to MDR class IIa or higher • “Uitstel is geen afstel” – the MDR certificate will have to be obtained at some point • up-classified means More (clinical) Data Really Clinical data from • studies or from literature (device or equivalent); and • post-market surveillance (PMS) or post-market clinical follow- up (PMCF) data • Start collecting that data now! • Draft and practice with Clinical Evaluation Plans, PMS plans, PMCF plans, PMCF evaluation reports, PMS reports and/or Periodic Safety Update Reports (PSUR) ahead of time
  18. 18. Timing to MDR CE certified • Somewhere before 26 May 2024 you must obtain a CE certificate under the MDR – you are still up-classified, remember? • Plan the transition right and don’t wait until the last moment with contacting a notified body • Towards the end of soft transition period notified bodies will be very busy with renewing (AI)MDD certificates to MDR ones and these will existing customers already so they will have priority • Plan transition sooner if possible to beat the crowd
  19. 19. WWBBD and sapere aude MDR mantra: “WWBBD?” “What would Brian Boitano do If he was here right now, He'd make a plan And he'd follow through, That's what Brian Boitano'd do.” Sapere aude! (‘dare to be wise’)
  20. 20. MDCG guidance coming
  21. 21. Nieuwe NL MDR & IVDR implementatiewet
  22. 22. A quote from the MDR QMS conference last week
  23. 23. Thanks for your attention! Erik Vollebregt Axon Lawyers Piet Heinkade 183 1019 HC Amsterdam T +31 88 650 6500 M +31 6 47 180 683 E erik.vollebregt@axonlawyers.com @meddevlegal B http://medicaldeviceslegal.com READ MY BLOG: http://medicaldeviceslegal.com

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