EU Accelerates Medtech Regulatory Reform Process
This article was originally published in The Gray Sheet
Executive Summary
Recent votes suggest a possible acceleration in the negotiation process on European reforms to device and diagnostic regulatory oversight on the continent.
You may also be interested in...
EU Council Resists Parliament Pressure To Pick Up The Pace On Reforms
The body representing European Union country heads of state continues to lag well behind the European Parliament progress on comprehensive device and diagnostic regulatory reforms, and is resistant to nudges to speed things up.
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.
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.