The MDCG « Medical Device Coordination Group » published on 20 April 2020 a series of 4 new guidelines, 2 related to clinical evaluation (MDCG 2020-5 and 6) and the 2 others (MDCG 2020-7 and 8) focusing on PMCF (Post-Market Clinical Follow-Up).

Such guidance document is not legally binding. It has been put together following contribution from national competent authorities, industry and relevant stakeholders and it should, therefore, be recognised as best practice.

This article is dedicated to MDCG 2020-5. Other guidelines will be discussed in subsequent articles.
The purpose of MDCG 2020-5 is to specify and clarify the expectations of MDR 2017/745 (EU) in terms of demonstrating equivalence with a device already on the market, in the context of CE marking.

This document analyses the differences between MEDDEV 2.7.1, rev. 4 and the MDR. It provides additional guidance on the 3 criteria required for deeming a device as “equivalent”:

 

• Technical Characteristics ( software algorithms are now considered as part of)
• Biological Characteristics ( exceptions for not using the same material are not allowed under MDR)
• Clinical Characteristics ( the type of user has also to be considered. It must be the same for equivalence claim)

A table is provided in Appendix 1 of MDCG 2020-5 to demonstrate equivalence. It can help to develop a template.

Specific attention to be given to:

 

• devices incorporating an ancillary drug substance: equivalence with the same device without the drug substance should not be claimed.
• for implantable and class III devices, in addition to obligations defined in Art. 61.4 of MDR 2017/745 (EU), equivalence with a device already placed on the market by another legal manufacturer can considered ONLY if this device is CE marked following MDR
  requirements.

This guidance also applies to non-medical devices (Annex XVI).