When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views
Executive Summary
When it comes to notified bodies deciding whether to undertake virtual audits or not in the context of the new EU medtech regulations, there are many elements that need considering and many different potential responses and cost implications. In this interview, BSI Netherlands explains its approach.
You may also be interested in...
Commission ‘Must Act’ Over Uncertain Virtual Audit Situation As Threat Looms Over MDR Certificates
The medtech sector has reached the point of exasperation over the European Commission’s handling of virtual audits under the MDR and IVDR. Advantages gained by having a delay in the MDR date of application could be all but lost.
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.