25/26 January 2023
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:
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.