Presentation at the October 2020 MedTech Summit regarding the notified body certification agreement for medical devices and IVDs

1. YOUR LEGAL
RELATIONSHIP
WITH YOUR
NOTIFIED BODY
MedTech Summit
12 October 2020
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• The ability to challenge: Can you challenge the legal decisions of your
Notified Body?
• Susceptibility to freedom of Information applications
• When is changing a Notified Body allowed?
• Legal advice on involuntary change of your Notified Body

3. Notified body regulation under
(AI)MDD, IVDD, MDR and IVDR
• CE marking has been a very successful public – private cooperation for
market access with many advantages, but also some disadvantages
• Nature of legal relationship with notified bodies is private law
agreement with mandatory legal elements overseen by national
competent authorities
• Very big changes with introduction Chapter 4 and Annex VII in the MDR
and IVDR
• As a result: MDR and IVDR notified body application process still
mostly stuck in application pipeline:

4. Can you negotiate your agreement
with a notified body?
• Certification agreement is part of the
joint assessment of the notified body
and blessed by the notifying Member
State (See Annex VII, § 4.3)
• Notified body has absolutely no
interest or obligation to negotiate
about it and it would get them in
trouble to for discriminating
customers

5. When do you have an agreement
with your notified body
• Sooner than you may think!
• Remember: you cannot apply for conformity assessment with
more than one NB per product at a time
• Don’t let your notified body lock you in before you realise
• One notified body excludes all others
• You won’t be able to change anymore without consequences

6. Can you challenge the legal
decisions of your Notified Body?
• One of the big problems under EU medical devices law (both directives
and regulations) is that there is no clear legal recourse
• Notified bodies must have internal appeals procedure
• When appeals procedure is exhausted, recourse depends on
national law
• Varies considerably from one Member State to the other
• US manufacturers: don’t send in the lawyers immediately
• You will ruin your chances to a practical solution

7. Can you challenge the legal
decisions of your Notified Body?
• Only real legal recourse option under MDR / IVDR directly is article 51
(2) MDR / 47 (2) IVDR – dispute about classification
• shall be referred for a decision to the competent authority of the
Member State in which the manufacturer / AR has its registered
place of business.
• Where the notified body concerned is established in a Member
State other than that of the manufacturer, the competent authority
shall adopt its decision after consultation with the competent
authority of the Member State that designated the notified body.

8. Susceptibility to freedom of
information applications
• Notified bodies have confidentiality obligations but not all information
they have is covered by this
• Authorities will have a lot of the information that notified bodies have, so
this may be obtained through national freedom of information requests
• Notified bodies may be in scope of local freedom of information law too

9. When is changing a Notified Body
allowed?
• Changing a notified body is always allowed but not always clever
• Directives had NBOG voluntary change procedure
• Art. 58 MDR / 53 IVDR – voluntary change of notified body
procedure requires handover agreement
• Guidance in MDCG 2019-6 v2 Questions and answers:
• Requirements relating to notified bodies, § IV.4

10. Legal advice on involuntary
change of your Notified Body
• A lot of opportunities for that:
• Brexit, Swixit and Turkxit
• Notified body does not make it through joint assessments for MDR
and/or IVDR
• Article 46 MDR / article 42 IVDR has procedure, but directives do not

11. 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