Regulating companion diagnostics: is it time for a major change?
This article was originally published in SRA
Executive Summary
Should the EU wait for the introduction of the forthcoming EU IVD Regulation (IVDR) to regulate companion diagnostics or should it create an entirely new and separate regulation for this product group? And if it does this now, could a new regulatory vehicle help to fast-track the IVDR and the Medical Device Regulation (MDR) that is also wending its way through the EU legislative process?
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.