New 'Transitional Measures' Taskforce To Answer EU's Most Critical Questions
A new EU taskforce has been set up to tackle implementation measures as the full extent of urgent actions needed to roll out the new regulations emerge.
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Impending Sense Of Regulatory Panic? EU's MDR/IVDR One Year On
It has been one year since the EU Medical Device and IVD Regulations took effect, leaving two years before the MDR fully applies and four before the IVDR fully applies. What has been achieved? And why is there a sense of panic among some in industry?
EU Industry Tells Authorities To Get Their Act Together As Pressure Builds
Six months into the transition period for the EU's Medical Device and IVD Regulations, the structures and resources needed to help medtech companies comply with the new rules are still far from being in place. Industry association MedTech Europe's concerns are mounting.
EU Roadmap: Catalyst For More Work, And A Long Way To Go
The EU Roadmap has been published. But it represents a dawning of a hard truth. The EU medtech sector still has a long way to go along the road to implementation before it gets the clarity it needs.