Will there be an Authorisation Obligation for Critical Medical Devices?

Since the PIP scandal (see our GMP-News from 22. February 2012), the EU has been working on strengthening the planned revision of the Medical Devices Guidelines. The European Parliament has proposed different measures in a resolution to get rid of the "malfunctioning of the system at European and national levels". Following measures are being discussed:

  • Implementation of a "pre-market authorisation" system for certain medical devices - including breast implants - comparable to medicinal products
  • Introduction of an implant recipient's "passport" containing the implant's specific characteristics and its potential adverse effects
  • Development of a breast implant register
  • Enhanced Market surveillance (including inspections)
  • Establishment of a European data base for medical devices providing information (monitoring data, clinical investigations, notified bodies, EC certificates) about medical products on the market.

The EU Commission addresses the first topic to its commissioner Dalli. It sees the introduction of an "authorisation system" dangerous because of over-regulation and connected inhibition for innovations. Instead, Dalli recommends stronger market monitoring. It will be interesting to see how development of medical devices regulations will evolve.

Details about the parliamentarians' proposals can be found in a press release of the EU.

Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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