Medical device legislation – current status of the upcoming revision
The European Commission, due to publish its proposals for a revision of the medical devices legislation, is expected to push back the publication to September 2012.
The European Commission had already an internal document ready to be published but the PID implant scandal obliged the Commission to perform stress tests in order to see whether a scandal could happen for a second time and how it could be avoided. In this sense, it is expected that the European Commission includes the main findings of the stress tests in its proposal and increase patient safety and market surveillance.
The debates ongoing in the European Parliament regarding a “Motion for a Resolution on Defective silicone gel breast implants made by French company PIP” provide a good idea on the Members of the European Parliament (MEPs) main interests in the area of medical devices. The discussion showed that there was a general agreement on the key issues such as increased traceability, the creation of a national and/or EU registry on implantable medical devices, pre- and post-market assessments and stricter rules for Notified Bodies. The main point of disagreement was on the inclusion of Clinical Investigations before receiving a CE mark for a medical device.
In more general terms, nothing further has been said about the Commission proposals as such. It would seem that the European Commission intends to review the three current medical devices directives through two regulations, one covering the area of medical devices and implantable medical devices and the second one covering the in vitro diagnostic medical devices.