October 23, 2013 | By Anabela Farrica
In the wake of the PIP breast implant scandal, involving the delivery of defective breast implants to hundreds of thousands of women, the European Commission decided to develop a new set of rules to govern the regulation of medical devices. This changes the regulatory environment of medical devices in the E.U., which is currently much more liberal than the U.S. system.
The proposed E.U. legislation, which includes a new centralized pre-market authorization system to regulate medical devices, aims at increasing the level of transparency and traceability of medical device manufacturing information. Currently, medical devices are granted marketing approval from organisations termed “notified bodies”, which are, to some extent, individually regulated by each member state. What the European Commission proposes is an additional pre-authorisation process similar to the one existing in the U.S. Such system will only apply to specific products, where a particular concern or a higher level of risk has been previously identified.
Yesterday (October 22nd), Members of the Parliament voted for the assembly of a number of new groups, which are meant to be responsible for the scrutiny of such high-risk devices. They also voted on the development of teams of experts inside the notified bodies “who meet up-to-date qualification requirements”.
Other elements of the new legislation include clearer responsibilities for the reprocessing of single-use devices, increased safety rules for the use of in-vitro diagnostic medical devices and the mandatory registry of implantable devices patients.
Although the law presents obvious benefits, such as increased public access to clinical data (allowing for better medical decisions, for example) and improved traceability of medical devices, critic voices noted that the novel requirements will lead to more, and unnecessary, bureaucracy. Industry groups also argue that such legislation will delay the arrival of many innovative products to the market, which in turn will take a toll on Europe’s competitiveness in the sector.
These new rules must still be approved by the governments of each of European Union’s 28 member states. The Parliament hopes to have their full endorsement by May 2014.