MedTech Europe’s Position Paper Aims To Smooth Certification Pathway For High-Risk IVDs

With the deadline for class D high-risk IVDs less than 18 months away and the underpinning regulatory structure still embryonic, MedTech Europe calls for clearer policies to give manufacturers a good chance of overcoming the regulatory challenges in time.  

Companies Should Have Aready Applied For Conformity Assessment Of Class D IVDs

It is important that all manufacturers who still need to apply for conformity assessment of their high-risk class D devices in the context of the IVD Regulation encounter improvements in the efficiency and predictability path to certification.

But, at present, manufacturers wishing to transition their class D IVDs to the IVDR “face numerous challenges.”

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