Medical device CE marking

Guidance for products without an intended medical purpose (MDR, Annex XVI)


The MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom) would like to share the following:

By May 2020, some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. These groups of products are listed under Annex XVI of the Medical Device Regulations (MDR). Further information about the specific requirements of the MDR on these groups can be found in this leaflet.

The leaflet can be downloaded here: library