Medical device CE marking

MDCG 2021-10 Status Appendixes E-I IMDRF N48


On June 4 the MDCG issued MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.

For ease of readability, this document intends to provide clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR. The examples provided within the Appendixes are for informative purposes and should not be interpreted as the sole manner for complying with UDI obligations. It is recommended that these documents are always read in conjunction with the MDR and the IVDR.

The document can be downloaded in our library

Source: European Commission