EU Offers Insight On New MDR Guidance Documents On The Horizon
Executive Summary
The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.
You may also be interested in...
Very Few Outstanding Items On European Commission’s Shrinking Rolling Plan
Most items have been ticked off the commission’s implementing plan now; but among the four items left, there is also a new proposal for an implementing regulation for Annex XVI products.
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.
European Regulatory Roundup, November 2022: EU MDR Situation Now Critical
Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.