When three EU medtech Directives become two Regulations - a quick run-through
This article was originally published in Clinica
Executive Summary
The two key documents relating to the EU Commission's proposals to revise the current medical device directives may run well over 100 pages long each, but in line with the commission’s simplification plan to cut the number of legislative texts applicable to any one sector, the array of EU medtech rules have been consolidated into two main medtech Regulations.
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.