Claiming equivalence per EU MDR 2017/745 Annex XIV Part A paragraph 3 may seem like an attractive route to obtain clinical evidence for a device under evaluation. However, Notified Bodies tend to be rather reluctant to declare conformity, if safety and performance are not supported with primary clinical data generated for the subject device itself.

MDCG 2020-6 Appendix III regards clinical trials as the highest level of evidence, while equivalence data ranks number 5 on the 12-rung ladder, thereby falling just below the cut-off minimum of level 4 that is expected for Class III legacy devices and implantable legacy devices that cannot be considered well-established technologies (WETs).

Still, claiming equivalence can be a viable option to retain a medical device on the regulated EU market, in the absence of sufficient high-quality clinical data pertaining to the subject device itself. If manufacturers decide to follow that strategy, EU MDR 2017/745 Annex XIV Part A paragraph 3 (as elaborated on in MDCG 2020-5) states that equivalence mandates Technical, Biological, and Clinical aspects to be either the same or similar to those of the device for which equivalence is claimed (see the equivalence table below).

Beware that, when providing justifications as to why any differences do not impact the safety or clinical performance of the subject device, the Notified Body expects to find the Clinical Evaluation Plan (CEP) clearly defining a comprehensive strategy, and the Clinical Evaluation Report (CER) to contain solid evidence (e.g., in the form of scientific articles) accompanying the submission.

For more information, visit: https://clinicalstudytemplates.com/clinical-evaluations-mdr/

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