March 2022
· 5 min read
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:
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.
NSF helps you navigate the process, from training and preparation of your technical files to consulting, technical file remediation, performance evaluation reports, and more.
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