The MDCG has released a guidance document relating to the equivalence for Annex XVI products, commonly referred to as Devices Without a Medical Intended Purpose. This is the second guidance document that has been released this month concerning Annex XVI devices. To offer some background to this guidance document, the MDR provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. Ideally carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking, however as previously mentioned, data from a device identified as identical could also be utilised.
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS.
The guidance document gives a total of 3 different scenarios for the demonstration of equivalence.
- Product without an intended medical purpose vs product without an intended medical purpose
- Product without an intended medical purpose vs analogous medical device
- Product without an intended medical purpose vs dual-purpose device
The guidance document can be accessed using the following link
