This document discusses current and proposed regulations around transparency and confidentiality for medical devices. Under current MDD rules, clinical evaluation information is not accessible to the public. The proposed MDR and IVDR would make more information publicly available through electronic databases, but commercial confidentiality would still be protected. Developments in pharmaceutical transparency show defining commercial confidentiality and allowing redaction. Overall, medical device rules aim to increase transparency while maintaining protections for proprietary information.

1. TRANSPARENCY AND
CONFIDENTIALITY IN
MEDICAL DEVICES
REGULATIONS
Innovation at the interface
30-31 October 2014
Erik Vollebregt
www.axonlawyers.com

2. Overview
• Current transparency and confidentiality rules under MDD
• Transparency and confidentiality under MDR and IVDR proposals
• Developments in pharma transparency and comparison with EMA policy
• National freedom of information rules

3. Transparency and Confidentiality under the MDD
Annex X, Clinical Evaluation
• Information exchange only between the competent authorities of the Member States and the Commission
• Such information is not accessible to the public (patients, healthcare professionals etc.)

4. Transparency and Confidentiality
under the MDD
However:
And:

5. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
Recital 39a

6. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
Transparency purposes of Eudamed (Article 27):
• to adequately inform the public about devices, certificates , ...with due regard to commercial
confidentiality where justified:
• to adequately inform the public and health professionals about clinical investigations and market
surveillance activities:

7. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
Electronic system on clinical investigations (Article 53):
• Only the information under(d) and (da) shall be accessible to the public
• The information under (b) and (c) shall be accessible only to the Commission and the
Member States
• Healthcare professionals shall have access too

8. Transparency and Confidentiality
under MDR
1st Reading of Parliament (2 April 2014)
• Adverse events and safety data are not commercially sensitive info

9. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
Electronic system on vigilance (Article 62):

10. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
The data entered in the electronic system on vigilance shall be accessible to (Article 62(2)):
• the competent authorities of the Member States
• the Commission
• notified bodies
• healthcare professionals
• manufacturers, where the information pertains to their own product
• public shall have access to the system at an appropriate level

11. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
Issues with the access of the public to the information in clinical investigations and
vigilance electronic systems:
• Public access to the electronic system on clinical investigations, Article 53(2) & 53(2a):
• healthcare professionals shall have access to the system too, but its not if they will
have access to all the information, and if not to which part of it.
• Remember recital 39a: access limitations only for other manufacturers?
• Does it mean that public may have access to all the information, even if it exceeds what
letters (d) and (da) of Article 53(1) allow?

12. Transparency and Confidentiality under MDR
1st Reading of Parliament (2 April 2014)
• Public access to the electronic system on vigilance (Article 62(3)):
- the term “appropriate level” is undefined.
- the level of access by public to this system is not restricted by the “commercially
sensitive information” criteria.
The level of access by public to this system’s data is too vague.

13. Transparency and Confidentiality under IVDR
Recitals 30 & 32a:

14. Transparency and Confidentiality under IVDR
• Article 24(1) and 24(1a) – Summary and clinical performance report:
The manufacturer of medical devices classified as class C & D (other than devices for
performance evaluation) shall draw up:
i) report on the safety and clinical performance of the device;
ii) a summary of the report, in a language easy to understand by the law person in the
country where the device is made available;
Only the summary shall be made available to the public via the Eudamed.

15. Transparency and Confidentiality under IVDR
• Article 51:
• Information under (b) and (c) shall be accessible only to the Commission and the MS.
• Information under (d) and (da) shall be accessible to the public in accordance with the
protection of personal data and commercially confidential information.
• Healthcare professionals shall have access too.

16. Transparency and Confidentiality under IVDR
• Article 60 – Electronic system on vigilance:

17. Transparency and Confidentiality under IVDR
The information entered in the electronic system on vigilance shall be accessible to:
• the competent authorities of the Member States
• the Commission
• the notified bodies
• healthcare professionals
• manufacturers, where the information pertains to their own product
• public shall have an `appropriate level` of access (the term is undefined)

18. Transparency and Confidentiality under IVDR
• Article 66 – Electronic system on market surveillance:
• competent authorities of the Member States, the Commission, the Agency (EMA) and the
healthcare professionals.
• public shall have access at an `appropriate level`.

19. Developments in Pharma
Transparency
• Both AbbVie and InterMune dropped their cases in the appeal phase
before the ECJ;
• EMA adopted Policy/0070 on publication of clinical data for medicinal
products for human use on 02/11/2014
• provides definition of CCI
• “CCI is defined, for the purpose of the policy, as 'any information contained in the
clinical reports submitted to the Agency by the applicant/marketing authorisation
holder (MAH) that is not in the public domain or publicly available and where
disclosure may undermine the legitimate economic interest of the applicant/MAH’.”
• contains a closed list of the sort of information that may be
considered as ‘commercially confidential’
• possibility to redact submitted information

20. Comparison (high level)
• MDR and IVDR apply undefined term ‘commercially sensitive data’,
while EMA policy does define this and has Annex I with CCI examples
• MDR and IVDR do not contemplate possibility to redact, while EMA does
• MDR and IVDR contemplate delegated acts (article 53 (3) MDR) while
EMA will use sets of ToU depending on
• access the data for general information purposes or
• academic and non-commercial research purposes
• EMA policy will apply only to clinical information under EMA
competence, MDR and IVDR will apply to all MDD and IVDD information
in the whole EEA

21. Comparison
Link to Annex D of EN 14155:2011 (Medical devices GCP) – Clinical
Investigation Report
D.1 General

22. Comparison
D.6.2 Clinical
investigation plan (CIP)
sub i) (statistical analysis)
D.7 Results sub f):
Performance analysis
D.6.2 Clinical investigation plan (CIP)
sub e) (subject population incl.
sample size)

23. Freedom of information nationally
• Notified body covered as emanation of state?
• NCA covered insofar as they have access to documents notified body?
• Freedom of Information request may be routed via manufacturer for
redaction

24. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E
erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com