Eucomed against new EU medtech regs' proposed scrutiny of devices while EDMA can live with it
This article was originally published in Clinica
Executive Summary
The European Commission’s lengthy consultation with industry over the revision of the medical device directives has paid off. The proposals for a Medical Device Regulation an IVD Regulation, just adopted by the commission, have genuinely been well received by industry – all except on one point. Amanda Maxwell spoke with the European industry associations for medical devices and IVDs, Eucomed and EDMA, including their new chief executive officer Serge Bernasconi, to ascertain their reactions
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.