European Commission Unlikely To Allow Virtual Audits Under MDR/IVDR In The Short Term
Executive Summary
The COVID-19 pandemic has made physical audits of manufacturers unsafe, and demand for auditing is set to reach its peak as the MDR application date looms. While some types of virtual audits are already allowed, others are not, leaving some device manufacturers in limbo.
You may also be interested in...
EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
EU Designates 17th Notified Body Under MDR
Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.
Industry Awaits Commission Ruling On Virtual Audits Under MDR
Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.
Need a specific report? 1000+ reports available Buy Reports
Register for our free email digests: