▶ Introduction
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment.
Whilst 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, clinical data can also be sourced from data of a device for which the equivalence to the device in question can be demonstrated. In such cases, equivalence shall be demonstrated according to the MDR requirements.
According to Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices, hereinafter referred to as CS, in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose where all available results of clinical investigations relate to medical devices only. Therefore, clinical investigations should be performed for products without an intended medical purpose.
The guidance document MDCG 2020-5 on “Clinical Evaluation – Equivalence” also covers the products without an intended medical purpose listed in the Annex XVI of MDR. It was issued in April 2020, before the availability of the CS and with the purposes of highlighting the differences between the MDR and the MEDDEV 2.7/1 rev.4.
MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies -
MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies - December 2023
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