Compromise Sought On Device Reform Proposal In European Parliament Committee
This article was originally published in The Gray Sheet
Executive Summary
Dagmar Roth-Behrendt, the legislator shepherding medical device reform legislation in the European Parliament, says she wants to work with the European Commission to establish a heightened market-access standard for high-risk devices, even if it falls short of her proposal for a full PMA-like review.
You may also be interested in...
Regulatory News In Brief
IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.
News In Brief
Boston Scientific acquires C.R. Bard’s electrophysiology business. European Council issues a progress report on device reforms. More news in brief.
Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament
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.