EU Medtech Sector 'Stunned' And 'Speechless' At Proposals For Further Delays To Eudamed Database
Executive Summary
Not enough resources and the lack of readiness of the clinical investigations module are being blamed for a possible further two-year delay in the launch of the EU’s critical medtech database.
You may also be interested in...
Member States Want Action Over High-Risk IVDs And Eudamed Medical Device Database
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.
First Dermal Filler CE-marked Under Annex XVI Of The EU's Medical Device Regulation
Austrian company Croma-Pharma is the trailblazer with its newly certified dermal filler.
Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel
The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.