Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament
This article was originally published in The Gray Sheet
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.
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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