EU Parliament’s Public Health Committee Debates Device Reform Proposal
This article was originally published in The Gray Sheet
Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.
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The three power centers in the European Union government have come close to alignment on a plan for a more centralized premarket "scrutiny" mechanism for medical devices in ongoing talks, according to sources. The same progress has apparently not been made for in vitro diagnostics yet.
The first of five "trilogue" meetings between the European Parliament, the Council of the European Union and the European Commission to reach a settlement on broad-reaching EU device and diagnostics regulatory reforms took place Oct. 13
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.