MDCG 2022-2 Guidance on General Principles of Clinical Evidence for IVDs

MDCG 2022-2 also describes how these activities should be aligned with requirements on risk management and post-market surveillance throughout the product life cycle.

MDCG 2022-2 is intended primarily for manufacturers, investigators and sponsors. It gives a synthetic view of the demonstration of clinical evidence and the process of performance evaluation (see figure 1, page 14). This document brings together many elements that have been addressed so far in different parts of the IVD Regulation.

Highlights include:

• The possibility to use data from an equivalent device; the topic of equivalence being almost non-existent in the Regulation (EU) 2017/746
• The importance of keeping aware of the state of the art and scientific advances which should be part of the manufacturer's post-market surveillance activities
• The role of risk management in performance assessment (Chapter 6.2), as clinical risks need to be considered in performance evaluation, performance studies and post-market performance follow up
• The addition of usability to the list of clinical performances compared to the list provided in the Regulation
• The description of the methodological principles for the generation of clinical evidence described in Annex I

Some questions are listed in Chapter 6.8. These questions help ensure that manufacturers have compiled the expected information in their performance review report.

Manufacturers should read this guidance in conjunction with the previously released MDCG 2020-1 guidance on performance evaluation of medical device software which provides information on how to establish clinical evidence for IVD software.

We already have had a guide from MedTech Europe but this one comes from the Competent Authorities and the European Commission and the release has been postponed many times.