Publication of Guide for Classification of Medical Devices Guide

Publication of Guide for Classification of Medical Devices Guide

In the European Union, Medical Devices are classified according to “Article 51 – Classification of Devices” and the “Rules” set out in “Annex VIII – CLASSIFICATION RULES” of Regulations (EU) 2017/745 and 2017/746 “. In many cases, applying the rules is difficult as more and more medical devices are innovative and therefore with a framework not foreseen in these rules.

The Medical Device’s risk classification is critical as it determines the applicability and extent of a set of procedures, such as the conformity assessment and clinical evaluation, that is essential to guarantee the performance and safety of the Medical Device. Thus, the importance of clarifying as much as possible the application of the rules in Annex VIII of Regulation (EU) 2017/745 on medical devices is perceived.

In this context, the working group “Medical Device Coordination Group (MDCG)” has just published a guide, “MDCG 2021-24 Guidance on classification of medical devices”. With this document, manufacturers now have a very useful tool that facilitates the application of classification rules.

The document is divided into four chapters:

1-Purpose of medical device classification.
2-Practical relevance of classification. This is an excellent summary of the impact of Device rating.
3-How to carry out classification. This chapter clarifies a set of definitions and then explains how to apply the rules.
4-Explanations of individual rules. Includes a visually unambiguous graphical representation of the application of the rules

Access the guide here.

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