Presentation at Vonlanthen webinar about how manufacturers of medical devices can work with EU exceptions under article 59 MDR.

1. HOW TO WORK
WITH EMERGENCY
RULES RELATING
TO COVID-19?
Vonlanthen webinar
14 May 2020
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• The EU recommendation on national exemptions to CE marking of
medical devices
• Interplay between national and EU law regarding emergency rules
• How will the move of the date of application affect?
• What will the new article 59 MDR powers of the Commission look like?
• What is the effect of the new remote audit’s guidance MDCG 2020-4 for
medical devices manufacturers?

3. MDR DoA postponed with one year
– industry be like

4. MDR DoA postponed with one year
– but will it make a difference?
• Can notified bodies quickly scale up (AI)MDD capacity again for one
year?
• (AI)MDD only NBs were planning for babysitting certificates in soft
transition after May 2020
• (AI)MDD plus MDR NBs were planning to switch over to MDR
conformity assessment as of end May 2020
• Even if there is capacity, can it be deployed?
• COVID-19 put an enormous stick in the wheel of ongoing
assessments
• MDCG 2020-4 guidance gives limited room for alternative audit
options

5. MDR DoA postponed with one year
– but will it make a difference?
• The Commission is also using the year for taking care of its own delays,
so CECP will not be available most of the time because expert
committees still need to be set up
• If all else fails, will article 59 MDR (which now also applies to AIMDD
and MDD) make a difference?

6. Commission Recommendation on
national exemptions
• Commission Recommendation (EU) 2020/403 on conformity
assessment and market surveillance provides recommendations within
the context of COVID-19
• Only for essential medical devices (not IVDs!) and PPE for
professionals (not for laypersons)
• Conformity assessment
• Member states: consider national exemptions, even when
notified body is not required
• Member States: consider ordering your notified bodies to
speed up pending conformity assessments

7. Commission Recommendation on
national exemptions
• Market surveillance
• Chase down non-compliant PPE
• Use time limited exemptions to allow devices and PPE on the
market that has not completed assessment
• Consider assessment in purchase process
• Inform Commission of measures taken

8. Remote audit guidance MDCG
2020-4 effect
• Will the MDCG remote audit guidance make the difference in the coming
year?
• Not for
• initial certification audits
• scope extension audits
• unannounced audits
• MDR / IVDR (although principles may be applied)
• Naughty manufacturers with a history / risk of non-compliance
• Alternative solutions possible if NB has procedures, e.g.
• Postponement according to NB QMS
• Off-site document assessment
• Recourse to MDSAP audit material

9. Remote audit guidance MDCG
2020-4 effect
• Intended for AIMDD and MDD
• surveillance audits
• audits conducted for re-certification purposes
• in cases where a manufacturer submits a change notification to a
notified body that would typically require on-site audit or
verification
• in cases where a manufacturer terminates (voluntarily or
involuntarily) its contract with a notified body and enters into a
contract with another notified body in respect of the conformity
assessment of the same device(s)
• Duration: for as long as COVID-19 has declared pandemic status at
WHO
• Notified body makes risk assessment in audit plan

10. Remote audit guidance MDCG
2020-4 effect
• If remote audit successful
• notified body may re-issue the certification, but:
• under the condition of follow up by an on-site verification audit
at the next available opportunity
• the timeline for the on-site verification audit should be
justified by the notified body
• verification audit verifies the elements that could not be
assessed remotely
• Remember: article 59 MDR exemption does not require NB audit!

11. Notified bodies on postponement
of DoA
• Team NB position on postponement of DoA:
• do what you were planning to do anyway like the delay never
happened
• No general statements or policy: remains highly individual situation for
the manufacturer’s own context

12. Article 59 MDR
Two changes with MDR DoA postponement amendment:
• AIMDD and MDD are covered by MDR until date of application
• Corresponding derogation provisions under AIMDD (Article 9(9)) and
MDD (Article 11(13)) are repealed – only MDR process now
“Taking into account the COVID-19 outbreak and the associated public
health crisis, the Commission should be able to adopt Union- wide
derogations in response to national derogations in order to address
potential Union-wide shortages of vitally important medical devices in an
effective manner. It is for that reason appropriate that the relevant provision
of Regulation (EU) 2017/745 applies at the earliest date possible and that
the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are
repealed from that date.”

13. Article 59 – it starts with a national
derogation decision
• National criteria not the same everywhere, so where to start?
• Commission Guidance on medical devices, active implantable
medical devices and in vitro diagnostic medical devices in the
COVID-19 context
• MDCG 2020-9 Regulatory requirements for ventilators and related
accessories
• Ask national authorities
• Expect COVID-19 related national procedures to be very different
from usual derogation procedures
• Look at scenarios discussed in MDCG 2020-9 for what MDCG
considers realistic scenarios, e.g.
• product line extension for existing legal manufacturer (§ 4.3.1)
• parts supplier becomes ‘legal’ manufacturer (§ 4.1.1)
• contract manufacturer becomes ‘legal’ manufacturer (§ 4.1.2
and 4.3.2)

14. Article 59 – it starts with a national
derogation decision
• Derogation from conformity assessment broader than named patient
typically involves appreciation of
• the degree of criticality of the use of the device for the protection
of health;
• availability of suitable substitutes;
• documentation of compliance with a harmonised standard or other
specific technical solutions ensuring fulfilment of the applicable
essential requirements laid down in the relevant Directive;
• review of reports of tests performed by competent bodies; and
• indications from vigilance and/or market surveillance

15. Article 59 – it starts with a national
derogation decision: timing
• Varies greatly from one Member State to the other
• MDCG 2020-9, § 4.2:
• “Timing to obtain a national derogation by a competent authority
will greatly depend on the quality and adequacy of the evidence
provided by the manufacturer.
• When technical documentation and evidence of safety of
performance is adequate, this can be a feasible option to ensure
short-term supply.”
• In other words:
• put in a well-founded application and receive a quick and positive
answer
• do not rely on authorities to do your homework, because they
won’t

16. Article 59 – it starts with a national
derogation decision
• National derogation is further temporary, linked to
• time strictly required for rendering the device compliant with the
legislation or, if earlier,
• when suitable substitutes can be expected or the critical needs
will no longer be present
• “Recent experience indicates that there is, in addition, a need to be
attentive to falsified certificates and counterfeit devices.”

17. Article 59 MDR: derogations from
what exactly?
Derogations made possible by Article 59 (1) MDR
• replaces (as of MDR amendment) national derogation measures
provisions Article 9(9) AIMDD and Art. 11(13) MDD
• concerns a specific device (not a group)
• derogation from conformity assessment (Articles 52 MDR, Article 9
(1) and (2) AIMDD and Article 11(1) to (6) MDD)
• can concern any kind of use of a specific device that should
normally be subject to conformity assessment
• “for which the procedures referred to in that Article have not
been carried out but use of which is in the interest of public
health or patient safety or health”
• authorisation to place a device on the Union market

18. Article 59 derogations - conditions
• Commission has initiative and discretion for EU level decision
• Commission has exclusive initiative to propose implementing act
• only in exceptional cases
• relating to public health or patient safety or health
• for limited period of time
• conditions under which the device may be placed on the market or
put into service are set in the implementing act
• No policy outlines yet, although the potential use is mentioned in several
policy documents (e.g. the COVID-19 Recommendation and MDCG
2020-9)
• “This allows the Commission and the Member States to address
potential shortages Union wide of vitally important medical
devices in an effective manner.” (MDCG 2020-9, § 4.2)

19. Article 59 MDR: the EU level
normal process
• Article 114 (3) MDR Committee procedure
• Commission has initiative, but…
• Committee controls by means of opinion by QMV

20. Article 59 MDR: the EU level
emergency process
• If duly justified imperative grounds of urgency relating to the health and
safety of humans
• the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 114(4) (article 8
Comitology procedure)
• Committee provides opinion ex post
• Commission repeals implementing act if negative opinion

21. Article 59 MDR: valid for Union
• Results in implementing act valid in the Union (not EU, but Union)
• Relevant concept with all the exits going on
• UK: not Union anymore after 31 December 2020, unless
transition prolonged in mutual agreement before 1 July 2020
• Switzerland: does not have MRA/IFA yet for MDR/IVDR, so
not Union upon DoA (now 26 May 2021)
• Turkey: MDR/IVDR not formally in recognition instrument
under Association Agreement framework , so not Union upon
DoA (now 26 May 2021)

22. Article 59 MDR: consequence of
exit
• Consequences of exits from Union are not provided for in MDR, but may
be provided for in national legislation
• MDR CE and (AI)MDD CE will (likely) be recognized by exiting
state
• Article 59 implementing act ≠ CE mark, so will need to be
addressed separately

23. Other national possibilities
• Named patient exemption for not CE marked device
• Off-label use of CE marked devices
• Do you have a nationally compliant off-label use procedure?
Typically includes:
• a documented risk assessment on the use of the device
• consideration of ethical and legal implications
• implementation of suitable precautions to minimise the
risk
• reviewing the risk assessment at suitable periods
• obtaining approval from the national competent
authorities when required.

24. 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
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