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.
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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.
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.
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.