EU “Trialogue” On Device Reforms Could Happen By Early Next Year
This article was originally published in The Gray Sheet
Executive Summary
Representatives of the three segments of the European Union government, the Parliament, Council and Commission, may begin formal talks on final legislative language to reform device and diagnostics regulations at the end of this year or early next year, according to the outgoing Greek presidency of the Council.
You may also be interested in...
Europe Urges Greater Alignment On U.S. And EU Device Review
The European Commission issued proposals for the next round of Transatlantic Trade and Investment Partnership talks, including support for a common device approval application for Europe and the U.S.
Surprise Inspections, And More, Coming Soon To The EU
It will be years before the device and diagnostic regulations proposed last month by the European Commission take effect, but policymakers are pressing forward to implement select reforms, including surprise facility inspections, on an interim basis by early next year.
EU Device Reform Proposal Adds More Government Scrutiny, But No FDA-Like Review Body
The recommendation attracting the most concern from industry: a new Medical Device Coordination Group that would have the option to scrutinize third-party pre-market assessment reports for select devices prior to marketing.