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EU MDR – Medical Devices

Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covered by the Active Implantable Medical Device Directive 90/385/EWG (AIMDD) but also a range of products without an intended medical purpose. This category includes devices similar to medical devices, as listed in Annex XVI

What is EU MDR?

The scope of the MDR includes products without an intended medical purpose, that are similar in principle to medical devices but without a specific medical intended purpose. Annex XVI of the MDR lists the six categories of products that are covered by this scope. The groups includes devices such as cosmetic contact lenses, tattoo removal lasers, equipment for liposuction, and others. Instead of showing a clinical benefit, manufacturers of such products are required to demonstrate their performance and safety in the clinical evaluation.


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