HC 163 Regulation of medical implants

Written evidence submitted by Jacqueline Minor, European Commission (PMI21)

I would like to thank the Members of the House of Commons' Science & Technology Committee for having given me the opportunity to provide the European Commission's views with regard to medical device regulation in the EU.

As I mentioned at the session on 13 June 2012, enhancing transparency of the regulatory system is one key element of the revision of the existing medical devices directives. The European databank on medical devices (Eudamed) should be further developed and become the central piece of an EU portal storing information regarding medical on the EU market and giving access to such information.

In future, Eudamed should be composed of the following electronic systems:

· an electronic system on Unique Device Identification (to allow traceability of medical devices),

· an electronic system on registration of devices and economic,

· an electronic system on information on certificates issued by notified bodies,

· an electronic system on clinical investigations in relation to medical devices,

· an electronic system on medical device incidents (vigilance), and

· an electronic system for sharing information on market surveillance activities of the Member States.

In the impact assessment carried out to prepare the draft legislative proposals, we estimated the approximate costs for setting up the future Eudamed databank with its various integrated electronic systems at EUR 2mio/year for a period of four years, followed by annual maintenance and development costs of EUR 1.8mio/year (including software for statistical analysis of reported incidents for signal detection).

Unfortunately, I cannot share with the Committee the draft legislative proposals which the Commission plans to adopt by the end of September 2012.

But I have compiled some draft provisions which relate to the subject-matter of my oral witness statement and which aim at enhancing the transparency of the system, ensuring traceability of medical devices, achieving a high level of commonality in the designation of notified bodies and making the vigilance system more effective.

Those provisions are part of the draft proposals which are currently subject to the consultation of the various Commission departments and remain internal documents. I would therefore ask you to keep this enclosed document strictly confidential. [1]

As part of Commissioner John Dalli’s plan for immediate action to restore trust in the regulatory system after the PIP incident, the European Commission is currently working, in cooperation with the Member States, on measures to strengthen the implementation of the existing medical devices directives. One measure aims at bridging the gaps in the practices of the Member States in relation to the designation and monitoring of notified bodies. The other measure aims at setting uniform criteria to be followed by notified bodies during the audits they perform under the medical devices directives. I enclose the two measures in their draft versions which are currently subject to stakeholder consultation and are therefore not confidential.

Enclosure: [2] 1 . Selected draft provisions from the proposal for a Regulation on medical devices

2. Draft Commission Regulation on the designation and the supervision of notified bodies under Directives 90/385/EEC on active implantable medical devices and 93/42/EEC on medical devices

3. Draft Commission Recommendation on the audits performed by notified bodies in the field of medical devices

[1] Not printed

[2] Not printed

Prepared 11th July 2012