Medtech Advised How To Stay On Top Of EU Regulatory Reform
This article was originally published in SRA
Executive Summary
Medtech companies should start reviewing sooner rather than later which of their product portfolios will remain on the market in Europe under the new Medical Device Regulation after the legislation is adopted. The next step will be to prioritize which of these products should be brought under compliance with the MDR first, then ensure timely assessments by notified bodies.
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.