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Member States Want Action Over High-Risk IVDs And Eudamed Medical Device Database

 
• By Amanda Maxwell

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.

Gloved hand performs COVID-19 testing in a laboratory setting.
Many High-risk, Class D, IVDs Will Miss Deadline Unless Given More Time • Source: Alamy (tilialucida / Alamy Stock Photo/Alamy Stock Photo)

EU member states want to see the May 2025 deadline for high-risk IVDs under the EU’s IVD Regulation postponed, as well as action to accelerate the date by which the Eudamed medical device database becomes fully functional in the context of both the Medical Device and IVD Regulations.

These were among suggestions put forward when representatives from 10 EU countries gave their opinions on the state of the EU medtech regulations at the 30 November European Employment, Social...

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