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Inside Medical Devices Updates on Developments for Medical Devices from Covington & Burling LLP

More Delays for the Vote on the New EU Regulations for Medical Devices and IVDs

Posted in Device Regulation in Europe

The long awaited vote by the Environment, Public Health and Food Safety (ENVI) Committee, the lead European Parliament Committee overseeing the revision of EU medical devices legislation, on the European Commission’s proposals for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices has been delayed for a second time.  In July, the ENVI Committee delayed the vote for two-months due to diverging views on the proposals.  The vote was then scheduled for September 18, 2013, but has been delayed for a week until September 25, 2013.  The European Parliament’s plenary vote to adopt the proposed Regulations and any ENVI Committee amendments also has been postponed until November 2013.

The ENVI Committee has postponed the vote on the proposed Regulations to allow additional time to reach a compromise on over 1,000 tabled amendments to the text of the Regulations and to draft proposed compromise amendments – which essentially aim to create a new position on contentious issues around the proposals.  Following a debate on the two proposed Regulations at the ENVI Committee meeting on May 29, 2013, it became clear that there was a divergence of opinion on the tabled amendments with the most controversial issue being the proposal to introduce a pre-marketing authorization system for high-risk and innovative devices (as announced in our previous post the ENVI rapporteur for the Regulation on medical devices, Mrs. Dagmar Roth-Behrendt, had proposed the introduction of a pre-marketing authorization regime for medical devices, but Mr. Peter Liese, the rapporteur for the Regulation on IVDs, has not proposed such a pre-marketing authorization for IVDs.)

Mrs. Dagmar Roth-Behrendt’s pre-authorization proposal also suffered a set-back in July.  On July 30, 2013, the European Parliament’s Committee on the Internal Market and Consumer Protection (IMCO) voted to adopt its opinion on the European Commission’s proposal for a Regulation on medical devices.  The IMCO’s opinion does not support the ENVI rapporteur’s pre-marketing authorization regime proposal, but does endorse the Commission’s scrutiny procedure (described in detail in our earlier post).  However, the IMCO suggests that the term “scrutiny” should be changed to “scientific assessment” reflecting that the results of the assessment should be binding and not simply constitute a consultation procedure.  Thus, a negative assessment would prevent devices from being certified and introduced on the market.

The voting delay has provided Mrs. Dagmar Roth-Behrendt more time to persuade Members of the European Parliament to support her pre-authorization proposal and to reach a proposed compromised amendment for the regime in order to avoid the risk of leaving the issue for debate at the plenary stage.  However, the proposal is still controversial and there remains uncertainty over which direction the ENVI Committee will vote in respect of the pre-marketing authorization regime during the vote next week.