Clarifying the role of equivalence and similarity in medical device conformity assessment under the MDR

English

The transition from the Medical Device Directive to Regulation (EU) 2017/745 (MDR) has significantly redefined the role of equivalence in the clinical evaluation of medical devices. While the MDR imposes stricter requirements, the use of clinical data from equivalent or similar devices remains possible – though under clearer, more structured conditions. This article by Dr. Sabine Bertsch and Florian Tolkmitt explores the evolving regulatory expectations surrounding equivalence and its practical implications for conformity assessment. It clarifies that, contrary to widespread belief, the use of equivalence is not entirely excluded under the MDR – even for high-risk devices – if appropriately justified through a thorough gap analysis covering technical, biological, and clinical characteristics. An optimised format for equivalence assessment is proposed to enhance transparency and usability. Drawing on guidance from Medical Device Coordination Group documents, the article outlines how data from both equivalent and similar devices can support regulatory compliance, even when direct claims of equivalence are not feasible. For example, clinical data from similar products play a critical role in risk management, establishing the state of the art, and defining clinical outcome parameters. Additionally, the concept of well-established technologies offers a regulatory pathway where similarity-based data may suffice, reducing the need for new clinical investigations. The article also addresses special considerations for implantable and Class III devices, emphasising the limited but valid use of equivalence.

Specification: 10 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the February 2026 issue of the Journal of Medical Device Regulation.