In the new position paper MDCG 2022-11, which has been published by the European Commission, manufacturers are requested to submit their applications for certification under MDR early and completely.

Herewith MDCG considers the fact that according to an information by TEAM-NB, the European association of Notified Bodies for medical devices, a majority of the members reported that more than half of the applications have to be considered as incomplete, which means that the quality management documentation or the technical documentation is not in status, which allows an assessment.

It is mentioned that Notified Bodies may not be in a position to perform an assessment of all technical documentations until May 2024. Further the document clarifies that potential exceptional approvals by national Competent Authorities can only be performed if the products concerned are needed in the interest of public health, patient safety of patient health.

mdc fully supports this call for timely applications, which are complete and compliant based on the experience with the MDR made so far. Complete submissions should be made to mdc already in 2022 in order to maintain a chance for a certification until May 2024.