Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track

1. TRANSPARENCY
UNDER THE MDR
AND IVDR
Informa MedTech Summit
14 June 2016
Presentator
www.axonadvocaten.nl

3. • Get it right or get it
wrong – mistakes will
impact your company
severely

4. Agenda
• What are the new transparency principles under the new regulations –
helicopter view
• What are the legal aspects of this?
• Industry perspective on transparency – questions surrounding the
requirements and is transparency a good thing?
• Views in this presentation based on Council general approach – and
adapted to agreed text published as much as possible

5. Transparency principles
Transparency objectives:
“Transparency and better information are essential in the public interest, to
protect public health, to empower patients and healthcare professionals and
to enable them to make informed decisions, to provide a sound basis for
regulatory decision-making and to build confidence in the regulatory system.”
(recital 35)
All information will be in Eudamed:
“The objectives of the database are to enhance overall transparency, to
streamline and facilitate the flow of information between economic operators,
notified bodies or sponsors and Member States as well as between Member
States among themselves and with the Commission, to avoid multiple
reporting requirements and to enhance the coordination between Member
States.” (recital 36)

6. Transparency principles

7. Eudamed
Access to Eudamed:
• Member states and Commission: unlimited access
• Rest (NoBos, economic operators, sponsors, HCPs and patients) on
need to know basis (“healthcare professionals and the public have
appropriate levels of access to the electronic system”)
• Commission lays down modalities necessary for the development and
management of Eudamed in implementing acts

8. What else will be public?
• Home brew devices declaration of hospitals (Article 4 (4a) (d))
• National measures on reprocessing (Article 15 (1b))
• UDI core data elements (Article 24a (1) and (1b))
• Economic operator and device registration data (Article 25a (6))
• Summary of safety and performance (Article 26) “if relevant” [???]
• Article 35 (5) – yearly member state notified body monitoring report
summary
• Annual Notified Body peer review report summary (Article 38)
• Information regarding certificates issued, including amendments and
supplements, and regarding suspended, reinstated, withdrawn or
refused certificates and restrictions imposed on certificates (Article 45
(4))

9. What else will be public?
• Article 53 (1) – all information about clinical trials going into the
electronic system for clinical trials (e.g. clinical investigation reports
(Article 57 (3 and 4))
• except communication between member states and Commission
and when confidentiality of the information is justified on any of
the following grounds:
• (a) protection of personal data in accordance with
Regulation (EC) No 45/2001;
• (b) protection of commercially confidential information,
especially in the investigators brochure, in particular
through taking into account the status of the conformity
assessment for the device, unless there is an overriding
public interest in disclosure,
• (c) effective supervision of the conduct of the clinical
investigation by the Member State(s) concerned;

10. What else will be public?
• Field Safety Notices (Article 63 (5))
• Summary of surveillance results (Article 67 (2))
• MDCG and expert panel members and their interests (Article 78 (2) and
81a (3))
• Scientific opinion and advice of MDCG expert panels, subject to Article
84

11. Freedom of information requests
Article 1 (8a):
Be prepared for freedom of information requests by patients and
competitors!

12. Did not make it through trilogue
1st Reading of Parliament (2 April 2014)
Recital 39a

14. 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
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