MDCG 2023-6: Equivalence Guidance for Annex XVI Devices

Introduction

The MDR (Regulation (EU) 2017/745 on medical devices) provides a pathway to incorporate clinical data from an equivalent device in the assessment of a device’s conformity. While conducting a clinical investigation is the conventional means of acquiring data for CE marking, the MDR allows the utilization of data from a device with demonstrated equivalence. The Commission Implementing Regulation (EU) 2022/2346 Common Specification (CS) outlines the challenge of demonstrating equivalence for products without an intended medical purpose when clinical investigations solely pertain to medical devices. Existing guidance, MDCG 2020-5 on “Clinical Evaluation – Equivalence,” predates the CS.

MDCG 2023-6 focuses on demonstrating equivalence for CE-marking purposes under the MDR, specifically for products without an intended medical purpose listed in Annex XVI and falling under the CS.

MDCG 2023-6 Key Takeaways

Products without an intended medical purpose vs. products without an intended medical purpose

Manufacturers must establish equivalence for products without an intended medical purpose based on criteria in the MDR, considering technical, biological, and clinical characteristics. The guidance clarifies how these characteristics apply to non-medical products.

Product without an intended medical purpose vs. analogous medical device

Comparing a medical device with a non-medical product proves challenging due to differing clinical characteristics. Equivalence cannot be established, as certain criteria, such as ‘similar severity and stage of disease,’ may not be applicable to non-medical products.

Product without an intended medical purpose vs. dual-purpose device

Equivalence can be demonstrated by comparing characteristics related to the non-medical purpose for both devices. Clinical data from a dual-purpose device, specific to general safety and performance requirements for the non-medical purpose, can be used for evaluating a product without an intended medical purpose.