In Vitro Diagnostic Medical Device Regulation Resources

Be confident of IVD medical device market approval

Be confident of IVD medical device market approval

ensure a smooth process while complying with the EU in vitro DIAGNOSTIC medical device regulation (IVDR)

The complex development process for in vitro diagnostic medical devices combined with the anticipated changes, can make the transition a complicated and time-consuming process for most device manufacturers.  

The resources below provide information and checklists to prepare you for EU's IVDR. Download these resources to ensure the latest information and guidance in your IVDR journey.

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