European Regulatory Roundup, April 2021: All Cylinders Firing On MDR And IVDR Front
Executive Summary
The EU MDR date of application is three weeks away; while this date may look more tenable than before, deadlines in 2022 and 2024 leave the medtech industry, and especially its IVD sector, wondering how to stop products being lost from the market.
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.