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European Parliament Committee Proposes Enhanced Device Reg Reforms

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.

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...

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