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.
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Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.
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.
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.