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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.

The European Parliament’s Public Health Committee approved a new pre-market review process for high-risk devices amid 30 accepted compromise amendments to medical device and diagnostic reform legislation Sept. 25.

The compromise authorization 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. (See Also see...

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