Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will become fully applicable on May 26, 2022. In this context, we would like to draw the reader’s attention to some very important points:
- All class A medical devices must be fully compliant to the IVDR by May 26, 2022. Exempted from full IVDR compliance are products that will require notified body involvement due to amended IVDR classification rules and that hold a valid IVDD CE certificate.
- Devices requiring full IVDR compliance as per the statement above that have not completed the corresponding IVDR conformity assessment procedure may not be placed on the market after May 25, 2022.
- IVD medical devices that may continue to be placed on the market under the IVDD beyond May 26, 2022 in accordance with article 110 of the IVDR, may only be sold under certain conditions. Please watch out for guidance documents that we expect to see released soon. We would advise to regard MDR guidance documents MDCG 2020-2 and MDCG 2020-3 in the interim.
Should you have any questions or concerns in this context, please don’t hesitate to get in touch.