On Wednesday 25 September 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) voted on two draft Regulations intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive.
Members of the European Parliament's (MEP) ENVI committee voted in favour of both MEPs Dagmar Roth-Behrendt and Dr. Liese's compromise and consolidated amendment packages on the proposed medical device Regulation and the proposed In Vitro Diagnostic (IVD) Regulation.
One amendment voted by the ENVI Committee risks being particularly controversial with the medical device industry. This is the proposal concerning high risk medical devices. The ENVI Committee voted in favour of a compromise amendment which would impact Class III medical devices, implantable devices, devices incorporating medicinal products, and Class D IVDs. For these medical devices, the proposed conformity assessment procedure would include the intervention of special notified bodies designated by the European Medicines Agency on the basis of specific staff qualification and training. These special notified bodies would be required to notify the European Commission of any applications for conformity assessment received from manufacturers concerning high-risk medical devices.
The European Commission would immediately transmit the notification and the accompanying documents to the Assessment Committee for Medical Devices (ACMD) that would be created for this purpose. The committee would provide an opinion on the preliminary conformity assessment, particularly on the robustness of related clinical data pertaining to the medical devices "on a case-by-case basis and taking into account for instance cases of novel devices or of devices for which a novel technology is being used".
The European Medical Technology Industry Association (EUCOMED) has immediately reacted to the vote by indicating that1 "the Committee has voted in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system."
Following the ENVI committee vote, the draft regulations must also be approved by the majority of the European Parliament in a plenary sitting. The forecast date of this plenary session is 22 October 2013. However, given the delay in the ENVI committee vote, a later date in November may be foreseen. Following the vote of the European Parliament, the proposed Regulations will be reviewed by the Council which is due to vote on 10 December 2013.