New Developments in the EU with regard to Medical Devices

After the "PIP scandal", the EU had announced a reform of the medical device regulation. Proposals were published in October 2012. Now, there are further developments. With the statement "Today the European Commission adopted two measures to improve the safety of medical devices fulfilling its commitment to restore patient confidence in the medical devices sector ...", the Commissions published two documents at the end of September: an Implementation Regulation clarifying the criteria to be met by notified bodies and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector. The goal of these documents was to tighten to existing regulations. Here are a few examples of the strengthened requirements presented by the Commission:

  • "A Member State shall only designate a notified body after a 'joint assessment' conducted with experts from the Commission and other Member States. The assessment reports shall be made available to all other Member States. "
  • Member States must carry out surveillance and monitoring of the notified bodies at certain intervals to ensure that they continuously live up to the requirements.  If this is not the case, the Member State has to withdraw the designation as notified body.
  • "Knowledge and experience requirements of the staff of the notified bodies to be required by Member States are clarified."
  • "It is now required that notified bodies shall randomly perform unannounced factory audits and, in this context, check adequate samples from the production. Failure to carry out random checks will result in the suspension or the withdrawal of the designation of the notified body."
  • "Where risks might be caused by the substitution or adulteration of raw-materials, such as in the PIP-case, a notified body shall also check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased. "

The restructuring considerations of medical devices regulations released in the same period - which had to be agreed on at the end of October - were all the more interesting. The vote on the first reading happened on 22 October 2013 and the proposals were adopted by a clear majority.

Change requests compared to the September versions haven't been fully taken into consideration. There will be changes regarding the topic marketing authorisation. The planned assessment procedure of high risk medical devices - at least - only applies to products in Class III and Class IIb for the administration of a medicinal product, and on to combinations between medical devices and tissues or cells of animal origin. "Special Notified Bodies" should take care of these high risk devices. The conformity assessment should be accompanied by a coordination group for medical devices (MDCG). The request to perform unannounced audits of the notified bodies has been reaffirmed.

Now, the ball is in the Council of Ministers' court. An agreement settlement  is planned for June 2014. The EU websites provide information about the course of the procedure regarding the regulations of medical devices and IVDs.

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