MedWatch

EU Commision working on solution for IVDR bottlenecks

The new EU regulation (IVDR) strikes fear into the industry, as a lack of notified bodies could cause bottlenecks in the certification process of in vitro diagnostics tests (IVDs). The EU Commission is working on a solution, reports Danish Minister of Health Magnus Heunicke.

Photo: Katrine Hørup Noer

In summer 2022, the new EU Regulation 2017/746 takes effect.

The regulation concerns in vitro diagnostic medical devices (IVDs), but several industry associations have criticized the time horizon as being unrealistic. June of this year saw Minister of Health Magnus Heunicke take up the concerns at an EPSCO meeting.

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