Attention Medical Device Manufacturers!!! MDCG 2022-11 Position Paper has been revised by EU Commission.
MDCG 2022-11 Rev.1 MDCG Position Paper-Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements, which contains calls for medical device manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements, has been revised and it was published on the EU Commission's website on 29 November 2023.
In the revised MDCG Position Paper; besides current status information regarding the implementation of MDR and IVDR is provided, it is emphasized that the MDR and IVDR certification process should be started as soon as possible by the manufacturers and applications should be submitted to notified bodies in a timely and complete manner in order to ensure that there are sufficient devices in the European market and that manufacturers can fulfill the requirements of the transition period in a timely manner. Calls that should be taken into account regarding the certification processes of notified bodies have also been added to the updated MDCG document.
You can access the “MDCG 2022-11 Rev.1 MDCG Position Paper-Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements” using the link below.
https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf