European Parliament Committee Proposes Enhanced Device Reg Reforms

Article preview from "The Gray Sheet" - August 12, 2013

 The Internal Market and Consumer Protection Committee approved amendments to the EU Commission’s proposal. The package includes tougher pre-market regulation and more stringent scrutiny of notified bodies compared to what the Commission floated last year.

European Parliament Committee Proposes Enhanced Device Reg Reforms

Article preview from "The Gray Sheet" - August 12, 2013

The Internal Market and Consumer Protection Committee of the European Parliament approved a package of amendments to the EU Commission’s proposed medical device regulation July 30, including tougher regulation of high-risk medical devices seeking conformity, more stringent scrutiny of notified bodies and other provisions aimed at strengthening consumer protections.

The vote was 32 for, none against and four abstaining on a package of 148 amendments. The proposal goes next to the Environment, Public Health and Food Safety Committee, which will vote on all amendments, Public Health’s and Internal Market’s, on Sept. 18.

The EU Commission’s original proposal was released Sept. 26, 2012. While the committee taking the lead on modifying the Commission’s proposal is the Public Health Committee, the Internal Market Committee also has jurisdiction. Dagmar Roth-Behrendt, the relatively left-wing German rapporteur for the Public Health Committee, took what industry sees as a particularly stringent stance in reforms she forwarded, proposing a full-fledged government pre-market authorization review process for high-risk devices. (See "Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament" — "The Gray Sheet," Apr. 22, 2013.) Nora Berra, the relatively right-wing French rapporteur of the Internal Market Committee, was expected to take a relatively more lenient stance toward medical device regulations. Berra previously indicated that she wanted to avoid “useless controls” on the medical device market.

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