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

1. CLASS I AND MDR
Erik Vollebregt
www.axonadvocaten.nl

3. Agenda
• Transition and Corrigendum
• Who is upclassified?
• The gap
• Further developments

5. MDD class I to MDR class I
MDD class I
device
MDR class I
Now 26 May 2020 at the latest
Step 1

7. 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

8. 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

12. 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

13. 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

14. Breaking: corrigendum 2
• Still to be approved
formally by member
states and by European
Parliament

15. Breaking: corrigendum 2

16. Breaking: corrigendum 2

17. 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)

18. 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

19. 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’?

20. What is not a significant change?

21. 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

22. 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)

23. 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

24. 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

25. 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’)

26. MDCG guidance coming

27. Nieuwe NL MDR & IVDR
implementatiewet

28. A quote from the MDR QMS
conference last week

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