Medical device CE marking

Notice to manufacturers to ensure timely compliance with MDR requirements


The European MDCG has issued a Revision 1 of the position paper timely compliance with MDR and IVDR requirements.

Six years have passed since the adoption of MDR and IVDR and the implementation of the regulations is advancing. The Regulations’ transitional provisions have been amended to give manufacturers and notified bodies more time to conduct the necessary conformity assessment procedures and to avert shortages of devices needed for the EU healthcare systems.

The MDCG calls to manufacturers to transition to the Regulations and submit their applications for certification without further delay.

Currently there are 42 MDR and 12 IVDR Notified Bodies accredited: NANDO database

The document can be downloaded in our library

Source: European Commission