August Break Over, ENVI Returns to Consider Overhaul of EU Device, IVD Regulatory Frameworks

| 10 September 2013

European legislators are preparing to once again take up proposed changes to the way the EU regulates medical devices and in vitro diagnostics, they revealed in a 10 September 2013 announcement.


Earlier in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) released draft reports calling for the establishment of more rigorous safeguard on medical devices and in vitro diagnostics after a series of notable regulatory failures, particularly with the former.

In response, ENVI Rapporteur Dagmar Roth-Behrendt drafted a plan for medical devices that would see the European Medicines Agency (EMA) given the task of reviewing medical devices under a new 35-member committee known as the Committee for the Authorisation of Medical Devices.

Other proposed changes include regulating devices under a "Class" system similar to that in place in the US, creating a centralized marketing procedure for implantable medical devices, new labeling requirements for reprocessed devices, the establishment of a new Medical Device Coordination Group (MDCG) to advise the European Commission on medical technology, and user fees for devices.

A full list of proposed changes may be found in Focus' earlier coverage on the subject. (Here) (Here)

A separate proposal authored by ENVI member Peter Liese also called for changes to the way in which IVDs are regulated, including:

  • IVD testing would be subject to an assessment by an ethics committee.
  • Member states could restrict the use of specific types of ICD devices.
  • Genetic testing would not be available to non-medical professionals.

Back in Action

Both proposals have generated a large amount of discussion, with the greatest amount focused on the medical device proposal by Roth-Behrendt.

Now, after a long August hiatus, the ENVI committee has returned and announced its intent to once again take up the subject of device and IVD regulation in its upcoming 18 September 2013 meeting.

While the scheduled meeting is relatively short at just 150 minutes in length, it will likely mark the start of a sustained process to try to see the legislation-or some version of it-passed through the European Parliament.

The 18 September meeting documents may be found on ENVI's website.

ENVI: Draft Agenda for 18 September 2013


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