Products, which stay class I under the MDR, must be in full compliance by May 26 2020!
MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true.
MDSS concern: Clients who have class I devices and higher risk class devices were also under the impression that their risk class I devices are also covered by the EC certificate for the higher risk class devices. This is not true. Please check in particular the accessories.
MDSS concern: Clients who mainly have In Vitro Diagnostic Medical Devices, were under the impression that their medical devices as well fall under the application date of the IVD Regulation. This is not true.
Conclusion: All risk class I devices (MDD/MDR) must comply by May 26. 2020!
This means the EC REP contract must be fully executed and the EC REP must have performed the tasks outlined in the Mandate for the risk class I devices by May 26. 2020! Otherwise the products cannot be sold in Europe.