EU votes for new medical device regulations
Medical device manufacturers will be subject to stiffer safety and performance rules, under the proposals backed by EU ministers on the 29 June.
The Council of Ministers, which brings together the national governments within the EU, has voted to approve proposed new medical device regulations and will now open talks with MEPs in a bid to agree final wording for the reforms.
Under its proposals, medical device manufacturers will be required to plan, conduct and document a clinical evaluation of their products, to demonstrate they meet safety and performance requirements, before they can be put on the market or used in the EU.
"The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate compliance with the relevant essential requirements on safety and performance which shall be appropriate to the characteristics of the device and its intended purpose," the proposals said.
Manufacturers will in some cases also have to ensure their devices are assessed for conformity with the new rules by independent 'notified bodies', whose activities would be overseen by regulators, before the devices can be sold or used in the trading bloc, according to the plans.
In a statement, MedTech Europe raised concern with the Council's proposals on pre-market checks that, it said are, “redundant” and "only serve to adversely impact the innovation and growth of the medical device industry".
The Council's proposals, if introduced, would also introduce new reporting obligations. Manufacturers of medical devices would need to be able to track incidents stemming from their devices when in use and to notify regulators immediately where the device presents a serious risk.
Latvia is the current president of the Council of Ministers and, Guntis Belēvičs, minister for health in Latvia, said: "[This] agreement is a decisive step forward to improve patient safety and strengthen European competitiveness. Further work both within the Council and between the Council and the European Parliament is, however, needed to ensure that the benefits of the new rules are put into practice."