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Medical Devices Regulation amendments published

On 29 May 2013, the Environment, Public Health and Food Safety (ENVI) Committee, the Committee responsible for the Medical Devices Regulation, met to discuss the amendments to the text.

The main issue discussed during this debate was the concept of a centralized procedure for market authorisation and pre-market authorisation. It was very clear from the discussions that Ms. Roth-Behrendt, whose group would represent 24% of the vote in the European Parliament, did not have a majority on the issue of pre-market authorisation of medical devices.

She indicated that she would be willing to compromise on this issue in favour of stronger notified bodies with in-house expertise in key areas.

It is likely that a compromise will be found in favour of greater oversight of notified bodies without pre-market authorisation or the establishment of a body responsible for such assessments within the European Medicines Agency (EMA).

  • Part 1 of the amendments can be found here.
  • Part 2 of the amendments can be found here.
  • Part 3 of the amendments can be found here.
  • Part 4 of the amendments can be found here.


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