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Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament

This article was originally published in The Gray Sheet

Executive Summary

A key legislator on device reform in the European Parliament has issued a strong call to establish pre-market authorization for high-risk devices in Europe, among other consequential regulatory changes.

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The compromise pre-market provisions merge components of a pre-market “scrutiny” procedure proposed last year by the European Commission and proposals from legislators seeking even stricter pre-market oversight. The CEO of the industry trade group Eucomed calls it a “PMA in disguise carried out on a case-by-case basis” and says it will harm innovation and patient access to new technologies if adopted.

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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.

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