Official: European Parliament Signs Off Council of EU’s 4 Extra Years For Class I Upclassified Devices
Executive Summary
Medtech industry gets best seasonal gift as Council of EU and European Parliament agree on longer transition period for upclassified Class I medical devices. But how many notified bodies are still auditing products under the medical device directives?
You may also be interested in...
Commission’s One-Year MDR Delay Text Contains EU-Wide Derogation Proposals Too
The race is now on to get formal adoption of European Commission proposal postponing the MDR by one year and allowing more devices on the market more quickly. But potential hurdles are in the way as experts advise caution.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.