Notified body capacity

The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified in accordance with the MDR and the IVDR within the transition periods provided for in the Regulations. The data gathered to date indicate that there are multiple causes that require a mix of solutions.

Read the MDCG 2022-14 here