Team-NB (the European association of notified bodies) has published a position paper on the IVD Regulation (2017/746) date of application, indicating that their member Notified Bodies would support maintaining the current May 2022 date of application, provided that the following conditions are met by the end of 2020:
- The tools necessary to perform conformity assessments are available and ready for use.
- At least 50% of the currently existing 22 Notified Bodies are designated under the IVDR.
If this is not possible, they suggest alternatives:
- Enlargement of the grace period to include moderate/low risk devices (class B) and low risk devices (A sterile). Follow corrigendum approach identical to class I under MDR.
- Postponement of the date of application of the IVDR, with the recommendation that the decision is taken by the end of 2020.