EU Regulatory Round-Up, August: Perceived Failures Linked To MDR/IVDR Implementation Result In Fresh Calls To Action

It is no secret that that the implementation of the EU’s Medical Device and IVD Regulations has been problematic. Now, despite most processes and documents being in place, experts are making fresh warnings and calling for radical changes.  

Top Stories EU

Two key documents released in August, a white paper from German industry associations VDGH and BVMed proposing fundamental changes in the regulation of medical devices, and a position paper from TEAM-NB calling for urgent stakeholder action, provided some critical food for thought over the traditional European holiday month.

The white paper, written in collaboration with expert medtech regulatory lawyer and founding partner at Axon Lawyers, Erik Vollebregt, focuses on the current damage to innovation caused by the...

More from Europe

More from Geography