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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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EU Parliament Panel OKs Pre-Market Review Process Derided By Industry

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.

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.

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