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IVDR

IVDD to IVDR: The transition to (EU) 2017/746

The In Vitro Diagnostics Medical Device Regulation (IVDR, officially: (EU) 2017/746) replaces the In Vitro Diagnostics Directive (IVDD) and is legally binding as of May 2022. In vitro diagnostic medical devices that have not been converted accordingly may only be marketed as of the date for as long as their CE certification is valid (five years after registration).

Please note the extended transition periods.

Basically, the requirements of the IVDR and the IVDD are similar. However, with the IVDR, the technical documentation must be more concrete and detailed. More extensive information is required in the following areas:

  • Reference to similar products and predecessor products
  • Toxicology
  • Biological materials
  • Unique Device Identification (UDI)

As experienced professionals, we can assist you with the conversion and registration of products in accordance with the IVDR. In our portfolio of consultants, we have experts in technical documentation to shorten the time to market for your products and avoid potential rework.

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