Last December, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2023-6, Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies, which deals with the demonstration of equivalence based on data from an existing device, for CE marking and under MDR (EU) 2017/745.
The guideline applies to products without an intended medical purpose (listed in Anx. XVI of the European Regulation) and dual-purpose devices in their non-medical purpose.
In general, the MDR (EU) 2017/745 states that the data for the clinical evaluation of a device can be the same as for another device that can be shown to be equivalent to it. However, this is not the case for products without a medical purpose; in fact – according to European Commission Regulation (EU) 2022/2346 laying down common specifications for products without a medical purpose listed in MDR (EU) 2017/745 – equivalence between a medical device and a product without an intended medical purpose cannot be demonstrated if all available results of clinical investigations relate exclusively to the medical device.
The guideline clarifies that to demonstrate equivalence between a device with a non-medical intended purpose and a medical device, the manufacturer must take into account the technical, biological and clinical characteristics of the products, under the European Regulation.
However, unlike technical and biological characteristics, clinical characteristics cannot be directly compared, i.e. it is not possible to compare a device without an intended medical purpose and a medical device from a clinical point of view. For example, the ‘similar severity and stage of disease’ characteristic is defined and available for the medical device but not for the device without an intended medical purpose.
In contrast, equivalence between a non-medical purpose device and a dual-purpose device can be demonstrated by comparing only the non-medical purpose characteristics of both devices. Furthermore, should equivalence be demonstrated, the clinical evaluation of the product without an intended medical purpose should only be based on the clinical data of the dual-purpose device.
The increase in the use of products without an intended medical purpose is prompting regulators to commit to providing guidelines that can help manufacturers make devices that increasingly meet safety and performance requirements to safeguard the end-users and patients’ health.
>>> Through the services of strategic-regulatory consulting, support to EC certification and if necessary, European Authorised Representative, Thema can help you implement the requirements of the MDR (EU) 2017/745.
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