Products without an intended medical purpose (Annex XVI) in EUDAMED
Browse medical devices in the “Products without an intended medical purpose (Annex XVI)” EMDN category registered in EUDAMED. Each result links to its manufacturer, certificates, and identifiers.
984 medical devices in EUDAMED
About the Products without an intended medical purpose (Annex XVI) category
This category is unusual: it covers products that have no intended medical purpose but are nonetheless regulated under the MDR because they share characteristics and risks with medical devices — examples named in Annex XVI include coloured (non-corrective) contact lenses, dermal fillers, and certain equipment for fat reduction. They were brought into scope so that their safety is assessed even though they are sold for cosmetic or aesthetic reasons. Common specifications adopted under the regulation set out how their conformity must be demonstrated.
Common questions
What does “products without an intended medical purpose” mean?
It refers to the Annex XVI groups — such as non-corrective coloured contact lenses, dermal and other facial fillers, and equipment for liposuction or fat reduction — that are sold for cosmetic or aesthetic use yet are regulated under the MDR because of the risks they pose.
Why are non-medical products covered by the MDR at all?
Annex XVI deliberately brings these groups into the MDR so that their safety and performance are assessed like comparable medical devices; the applicable requirements are set out in the common specifications adopted for each Annex XVI group.