In June, a Position paper MDCG 2022-11 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The document does not reflect the official position of the European Commission. Any views expressed in this document are not legally binding.
MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements was issued on 13 June 2022. In the document MDCG points out that in order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
It should be noted that around 70 % of AIMDD/MDD certificates will expire in 2024 (by 26 May 2024 at the latest). Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024.
Click here for more information.
Do you need additional knowledge or assistance in meeting the requirements of MDR/IVDR?