A guide based on the experiences of the Johner Institute and Oliver Hilgers and Stefan Bolleininger

The discussions about class I software never stop. This article provides assistance in classifying medical software according to the rules of the MDR.

1. Background a) Relevance of the question

Whether medical software counts as Class I software is important for manufacturers as well as for authorities and notified bodies:

The authorities are “responsible” for class I software, and the notified bodies for software in the higher risk classes. The latter are completely overburdened despite the fact that the transition periods have been extended again. As a result, the manufacturers of medical devices are hardly able to bring innovative medical software to the market in a timely manner. She is lacking in patient care.

If software is unnecessarily upgraded by the authorities, non-critical products also "clog" the bottleneck at the notified bodies. In addition, the competitiveness of manufacturers suffers.

The authors have been observing this overregulation more and more recently. If, on the other hand, software is unjustifiably classified too low, it will not be "monitored" by the notified bodies, as desired by the legislator.

Caution!

Please note that the requirements for the software and its documentation are almost independent of the classification. For example, the essential safety and performance requirements in Annex I (almost) do not distinguish between products of different classes.

b) Purpose and limits of this article

This article is intended to provide more clarity in order to avoid unnecessary and time-consuming discussions and incorrect classifications. It does not aim to soften existing rules. Rather, it is about compensating for the errors, gaps and inconsistencies in the legal requirements described in Section 4.a) in the sense of the legislator.

2. Legal Framework for Class I Software a) MDR

The legal basis for the classification of software is exclusively Annex VIII of the MDR, in particular Rule 11.

b) MDCG guidelines

The MDCG has published guidelines for the classification of products:

  • MDCG 2019-11 for classification of software
  • MDCG 2021-24 for the classification of medical devices

However, these guidelines are not legally binding. They allow economic operators the flexibility to use or not to use them:

Having regard to the status of guidance documents, economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements.

MDCG 2022-14, section 11

However, legal relevance can arise when a guideline is used in a court decision. This happened, for example, in a judgment of the European Court of Justice with reference to MEDDEV 2.1/6.

c) IMDRF

The MDCG document 2019-11 in turn references an IMDRF document for the qualification and classification of software. This makes their classification scheme indirectly relevant for decisions about Class I software.

3. Classification of Class I Software a) Overview

The following overview summarizes the legal requirements of Rule 11 of Annex VIII of the MDR in a decision tree. There is therefore definitely software that falls into Class I.

In the following sections we will explain each step (indicated by a number in brackets in the diagram).

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