Advamed Med Tech 2019 countdown presentation
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The document discusses the current state of the Medical Device Regulation (MDR) implementation as of September 2019, highlighting the challenges faced by notified bodies and manufacturers, including capacity issues and the looming deadline for compliance. It addresses complexities around international coordination, particularly concerning Switzerland and Turkey's status in relation to MDR, as well as the overall uncertainty in the regulatory landscape. The need for manufacturers to prepare for various contingencies and to remain agile in response to evolving guidance and institutional changes is emphasized.
Advamed Med Tech 2019 countdown presentation
- 1. MDR COUNTDOWN: STATE OF IMPLEMENTATION Advamed MedTech 2019 25 September 2019 Erik Vollebregt www.axonadvocaten.nl
- 2. Clock is ticking towards DoA for MDR • We are well past two thirds of the MDR implementation period • Four notified bodies accredited for MDR • Some big notified bodies threw in the towel for MDR and (AI)MDD
- 3. Agenda • Implementation deadlines • The knowns and the unknowns • The notified body conundrum • What is there left to do between now and DoA?
- 6. Implementation deadlines • First companies with up-classified class I devices are finding that they will not have an MDR certificate in time for DoA • Software, inhalers, reusable surgical instruments • Notified bodies try to keep customers in house with Jedi mind trick No panic - we will be MDR accredited in time to certify your product. Ehhh – OK, I hope …
- 7. International developments • Other countries respond to MDR and IVDR related issues • US and Australia raise concerns about NB capacity • Australia expands scope of recognized entities • EU Council says ‘concerned’ after German and Irish alarm but no public measures (yet)
- 8. International developments • Confusion and misunderstanding about Swiss MRA and Turkey Association Agreement • Is Switzerland Union for the purposes of MDR and IVDR or not? • Switzerland is playing chicken with EU about comprehensive MR package replacing among others MRA covering devices • Is Turkey Union for the purposes of MDR or IVDR or not? • Turkish political climate for MDR / IVDR implementation changes as EU is requiring human rights and media improvements in return for mutual recognition • Potential far-reaching consequences for supply chains running through these countries
- 10. Implementation with an unfinished regulatory system
- 11. Implementation generally Which What Known knowns • MDR text • Rolling Plan that keeps changing • When to apply at notified body for (AI)MDD recert? • Corrigendum – dots, commas and no transition amended Known unknowns • Corrigendum no 2 – class Ir but anything else? • Common specifications • Implementing acts • What standards will be harmonised? • A lot of guidance (except MDCG stuff on UDI, PRRC, implant card and CAMD Q&A) • Eudamed functionality by March 2020 – but which parts? • National implementation – but which member states and how? • Your notified body accredited to the scope you need? • Your notified body ready to accept MDR or MDD cert (re)application? • Your notified body not shutting down on you? Unknown unknowns • National enforcement in case of • bottleneck induced shortages • notified body failing to deliver MDR certificate timely All over the place unpredictably crazy • Brexit – plan for a hard Brexit and have plans B and C
- 12. Pressure points implementation • Options and time to implement them are shrinking rapidly • Sitting on your hands is not an option because reality will paint you into a corner • You will have to work with what is there and plan for last moment corrections
- 13. Implementation • Steady stream of UDI related guidance by MDCG • Not that helpful PRRC guidance • More CS are slowly becoming available • Annex XVI products • Reprocessing • Implementing decision on expert panels for PFKAS (Procedure Formerly Known As Scrutiny (Clinical Evaluation Consultation Procedure)
- 14. Extension of deadlines? • Rumor: Corrigendum 2 in the works • Will likely concern a ‘correction’ of article 120 (3) MDR as regards class Ir devices and need to have a Ir certificate by DoA (26 May 2020) • Will likely cover entire soft transition period (26 May 2020 - 27 May 2024) • No other extensions foreseen • But more persistent rumors • Other up-classified class I devices may be covered too
- 15. Reshuffling in Commission • Under the new Commission the Medical Devices unit will go back to DG SANCO • (which is where it came from in the first place) • Not clear what people from Devices unit in DG Growth will transfer (back) to DG SANCO • Possible loss of expertise and momentum • Possible change of policy under new Commissioner
- 16. The notified body conundrum and landscape
- 17. Notified Body Capacity vs. Workload vs. TIME Full chart available here: http://www.medtecheurope.org/sites/default/ files/resource_items/files/MTE_Infographic_NotifiedBodies_CrunchTime_Sept2018.pdf
- 18. Notified bodies landscape • MDR : four notified bodies designated, of which sometimes significant scope restrictions • E.g. not Annex X (type examination) (BSI and Dekra Germany) • E.g. not class III devices (IMQ) • E.g. not breast implants (TUV SUD and Dekra Germany) • IVDR: none yet but likely soon • Rumors rumors rumors – 20 NBs designated by the end of the year? • More NBs on the way further to the next MDCG meeting
- 19. Notified bodies landscape • Issues start to arise with notified bodies (partially) laying down service in sight of MDR deadline • LRQA, UL, AMTAC/Intertek but also others • Orphaning not a solution for certificates from UK notified bodies: Commission takes view that hard Brexit ends orphaning by member states • Notified bodies more and more under capacity pressure • A lot of disruptions and certificate issues resulting from lack of capacity (renewal audits missed, sudden extra requirements (especially in clinical) resulting in certificates suspended or not renewed)
- 20. Notified bodies landscape • Concept of ‘significant change’ still not crystalized • Crucial to understand for manufacturers relying on ‘soft transition’ (2020-2024 exemption under article 120 (3) MDR) • Determines M&A structuring for all manufacturers that rely on soft transition • anything other than a shares transfer without reorganization will likely cause a significant change that will lead to instant loss of certificates • Merger pre-closing or post-closing commitments must be carefully drafted as not to cause a significant change • Notified bodies have no time to review anything quickly in view of MDR deadlines
- 21. Notified bodies landscape • BSI UK issues first CE certificate under MDR on 2 September 2019 • TUV SUD close on their heels with class III software device • Class IIa device under rule 20 (‘simple’ inhaler for medicines)
- 22. Notified bodies are closing down
- 23. Consequences of NB ceasing operation • Notified body gives max 90 days notice • After that period, your CE certificates are invalid, no matter the date on them • Within that period you must be onboarded by another notified body • Basically impossible to do within 90 days • Be prepared for orphaning scenario (max 12 months under wings of a competent authority pending NB onboarding) • Make sure you understand the scenarios and conditions (which CA to go to, how does their procedure work, etc.) • Commission takes the view that a hard Brexit ends all ongoing orphaning of UK NB certificates
- 24. What is there left to do between now and DoA?
- 25. What is there left to do until DoA? • First NBs are up and running and inventing the wheel in the first audits: gain experience from that • So far only BSI and TUV SUD seem to have been doing QMS audits on a very limited number of manufacturers • Approaches seem different based on differences in QMS philosophy
- 26. What is there left to do until DoA? • Be ready to pivot based on new EU guidance becoming available • CAMD still seems to be working on things • Get the economic operator stuff right • PRRC guidance less than comprehensive • Industry struggles to understand degree of independence required for AR and PRRC • New Market Surveillance Regulation (Regulation (EU) 1020/2019 • Keep your friends (crucial suppliers) close and your notified body closer
- 27. What is there left to do until DoA? • Be ready to implement Eudamed interfacing and process, have SRN (if OUS Union then have AR with SRN first) and prepare for UDI • Eudamed big bang release not expected anymore • Staged release of modules in three batches (March 2020, November 2020, May 2021) • Or: Eudamed may not be ready at all • Be intelligent with long term commitments (e.g. tenders) • Can you guarantee supply of every device over the next five years? • Do you have a plan B?
- 28. What is there left to do until DoA? Plans B • Have plan B for scenarios: • Hard Brexit • Switzerland and Turkey not being Union under MDR • Notified body calamities • NB shuts down / certs invalid as a result of Brexit, Swiss or Turkish dependency • NB misses MDR deadline for either (AI)MDD or MDR (re)certification • Other problems with organisation / certification status that lead to disruptions • Understand supply chain and concept of placing on the market • Have supply chain scenarios • Understand national exemption regimes for essential devices
- 29. 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
Editor's Notes
- #18: The capacity and workload of the Notified Body system are like supply and demand of a product in a free market. Over time, these are bound to balance out and return to equilibrium (because Notified Bodies will scale up their capacity to meet business demand) The problem, however, is that we don't have time. The MDR and IVDR dates of application are in May 2020 and May 2022 respectively Several Notified Bodies are staffing up as we speak, but it takes 1-2 years before a new recruit meaningfully adds to the organization’s capacity So, unless authorities proactively close the capacity/workload gap - whether through more time, or decreased workload, or both - the gap will correct itself, in the form of good products, needlessly lost from the market and healthcare system (i.e., a form of decreased workload...)