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Public Health

Manufacturers of devices without an intended medical purpose

Regulation (EU) 2017/745 on medical devices (MDR) covers some devices without an intended medical purpose. These are similar to medical devices in terms of functioning and risk profile. Annex XVI to MDR contains the list of the groups of devices concerned.

Commission Implementing Regulation (EU) 2022/2346, as amended by Implementing Regulation (EU) 2023/1194, lays down common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI to the MDR.

Commission Implementing Regulation (EU) 2022/2347 lays down rules for the application of the MDR as regards reclassification of groups of certain active products without an intended medical purpose.