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TRANSPARENCY UNDER THE MDR AND IVDR
Informa MedTech Summit14 June 2016
Presentatorwww.axonadvocaten.nl
• Get it right or get it wrong – mistakes will impact your company severely
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
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)
Transparency principles
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
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supplements, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates (Article 45 (4))
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;
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
Freedom of information requests
Article 1 (8a):
Be prepared for freedom of information requests by patients and competitors!
Did not make it through trilogue1st Reading of Parliament (2 April 2014)
Recital 39a
Wha
t is “c
orres
pond
ing”?
“hig
h-ris
k de
vice”
– o
nly
class
III?
Not “
low
risk”
?
Parli
amen
t pro
pose
s th
at
they
are
, act
ually
“All”
data?
Not re use by others?
www.axonlawyers.com
THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500M +31 6 47 180 683
E [email protected] @meddevlegalB http://medicaldeviceslegal.com
READ MY BLOG:http://medicaldeviceslegal.com
