Europe to feel French force over next six months
This article was originally published in Clinica
Executive Summary
Alarm bells may be ringing for those who do not want to see radical changes to the EU medtech regulatory system. France, which has a reputation for driving tighter requirements for medtech products in the context of the current EU medical device directives, takes over the presidency of the European Council of Ministers on July 1 from Slovenia.
You may also be interested in...
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.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.