Is each egg alike the other in the box? The guidance MDCG 2020-5 “Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies”, which has been available in its original version since April 2020, addresses the requirements for and the actual drafting of the equivalence assessment when preparing clinical evaluations. Generally speaking, the equivalence assessment should be carried out according to the valid rules of the MDR. The specifications and recommendations of MEDDEV 2.7/1 Rev. 4 continue to have their justification even three years after the MDR came into force; nevertheless, there are deviations from MDR which are discussed in the MDCG 2020-5 document without introducing new aspects and specifications. Only the MDR remains legally binding, but the guidelines are to be understood and taken into account as “state of the art”.
In the same wording as the MDR, MEDDEV 2.7/1 Rev. 4 requires that technical, biological and clinical characteristics must be taken into account when assessing equivalence when preparing a clinical evaluation based on the equivalence principle. The differences between the MDR criteria and the MEDDEV 2.7/1 Rev. 4 criteria regarding the evaluation of these three characteristics are addressed in the MDCG 2020-5 document.
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