EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.  

filmfoto/Alamy Stock Photo
(filmfoto / Alamy Stock Photo/Alamy Stock Photo)

The amending regulation introducing new transition provisions for certain IVDs within the scope of the EU IVD Regulation has been published in the Official Journal of the EU and formally came into force on 25 January.

The text also introduces a deferred application of conditions for in-house devices. But there is still some discussion about...

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