European Regulatory Roundup, May 2022: IVDR Applies And MDR Critics Clamor Loudly For Action
Executive Summary
This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.
You may also be interested in...
EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation
A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.
EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation
A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.
Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.