NEN symposium on Medical Devices and IVD Regulation
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Presentation about implementation of the MDR and IVDR and what companies need to do before the date of application of both of these regulations.
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NEN symposium on Medical Devices and IVD Regulation
- 1. HOE WAT WAAR MDR NEN MDR symposium 27 maart 2018 Erik Vollebregt www.axonadvocaten.nl
- 2. Main challenge for most companies • Overcome inertia and start attacking this thing – it will be a lot of work • Not ready in time means no more placing product on the market - there is no grandfathering
- 3. • Company risks not being ready by deadlines • Company risks pressure cooker process with uncertain outcome • Management often does not understand implications because RA is not very blunt about what is at risk (and that no choices have consequences) Better not: head in sand
- 4. • ”There is too much to do with ISO, MDSAP etc, so government is asking unrealistic things and they’ll have no choice but to give us a break.” • “The EU has no choice but to do this differently, because it will be a mess.” o ”So we wait and see what we really need to do” Try to be Chuck Norris
- 5. An overall plan could look like this
- 9. Leading principle: no grandfathering & no moving of implementation deadlines • All devices on the market are phased into the new system by the end of transitional period • This means that you have to do a new conformity assessment under the new rules for all devices currently on the market or remove the product from the market • If you don’t have a new CE under MDR or IVDR, you cannot place new product on the market after transition period • Do not count on the EU “having to move deadlines because it will be chaos”, as this would be unprecedented
- 10. Transition planning Slide: Gert Bos at DIA Euromeeting 2017
- 11. Credits: Joachim Wilke, Medtronic
- 12. Act now or perish • Implement program governance structure • Divide resources over project teams • Define project charter per team • Implement continuous improvement cycle • Plan Do Check Act • Watch dependencies • Stay informed via different sources (FHI, Nefemed, NEN) • Resourcing • Internal commitment • Board level • Management level • Staff level
- 13. Transition regime • When will you plan what?
- 14. Bottlenecks ‘soft transition’ • Be careful with ‘soft transition’ • Article 120 (3) restrictions • No significant changes in design and intended purpose • MDR level controls and obligations • Notified body cannot be changed anymore
- 15. Transitional regime bottlenecks – not for class I • Transitional regime works only for existing certificates or certificates obtained during transitional period • Big problem for any device currently class I partially (M/S) or fully self-certified • Notably software and substance based devices • Every up-classified currently class I device must be MDR certified before DoA • In other words: the group with the least experience with CE certification processes will need to get it right in the shortest timeframe and with notified bodies that are just starting to settle in their new MDR designation
- 16. Transition dependencies Notified body designation for class D batch testing follows after establishment and designation of reference labs • Notified bodies must be designated pursuant to application • Reference labs must be designated pursuant to application (art. 100 IVDR) but that doesn’t start until 25 November 2020 (art. 113 (1) (d))
- 17. Concurrent privacy by design requirements under GDPR • General Data Protection Regulation has already entered into force, transitional period ending 25 May 2018 • Will apply to any device that processes personal data, both on hardware and software level – possible overlaps with MDR • Relevant for everything clinical • Requires privacy by • Design • Default • Requires cybersecurity measures
- 18. Check out our hospital specifics:
- 19. www.axonlawyers.com 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
- Implants Inc considers the following recertification process: 1. MDR certification of their two QM – systems will be scheduled end of year two/beginning of year 3 to be ready for mandatory MDR product certifications after DOA (class I * products before DOA). 2. However the MDD QMS certificates will be renewed in the three year transitions period to exceed the DOA deadline. 3. The two high sales class III products and the implantable class IIb product will be transferred to MDR as soon as their MDD certificate expires or the survey studies are finished (in year 3). Unfortunately the certs of the class III product with excellent clinical data expires already early in year 2. However at this point in time no NB will be MDR designated. Smart HCS considers to convert this certificate nevertheless already in year 3 for marketing reasons. 4. All other class IIa/b products will be moved step by step from MDD to MDR as soon as their labeling and technical documentation has been MDR compliant updated and after the MDR QMS certs have been granted. Some products with low sales volume may be discontinued in case NBs require additional studies for clinical data. The post DOA MDD QMS certificate expire date shall be met. 5. All class I technical documentations and labeling will be step by step MDR compliant updated before DOA.