Will there be a Registration Obligation for critical Medical Devices?

Following the PIP scandal (See our GMP News from 22. February) the EU currently deals more intensively with the planned revision of medical devices regulation. In a resolution the European Parliament has now proposed various measures to eliminate the "system's malfunctions on a European and a national level". The following measures are currently being discussed:

  • Introduction of a "pre-market authorisation" system for certain medical devices, including breast implants - comparable to medicinal products
  • Introduction of an implant pass comprising specific characteristics of the implant as well as possible side effects
  • Introduction of a breast implant register
  • Increased market surveillance (including inspections)
  • Establishment of a European database for medical devices which will comprise information on medical devices currently on the market - like monitoring data, clinical studies, information of designated authorities, EU certificates

The EU Commission with commissioner Dalli is objecting to the first measure. For the commission the introduction of an "authorisation system" bears the risk of an "overregulation" for medical devices that would also impede innovations. Dalli instead prefers a more stringent market monitoring. It will be interesting to see in what direction medical devices regulation will move.

More details with regard to the parliamentarians' suggestions are available in the EU press release "Breast implants: Parliament proposes stricter safety checks."

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

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