The MDR contains a classification rule specifically for software: Rule 11 . This rule 11 is explosive! It has the potential to further weaken innovative strength in Europe.

Manufacturers should know the interpretation of the MDCG in order to avoid misclassification of software and to be able to follow the arguments of notified bodies and authorities. You will get to know this interpretation in this article.

1. Content of MDR rule 11

Rule 11 of Chapter III in Annex VIII of the MDR states the following:

"Software that is designed to provide information that can be used to make decisions for diagnostic or therapeutic purposes belongs to class IIa, unless these decisions have effects that can cause:

  • death or irreversible deterioration in a person's health; in this case it is assigned to class III, or;
  • a serious deterioration in a person's health or surgery; in this case it is assigned to class IIb.

Software intended for the control of physiological processes belongs to class IIa, unless it is intended for the control of vital physiological parameters, the way in which these parameters are changed could lead to an immediate danger for the patient; in this case it is assigned to class IIb.

All other software is assigned to class I. "

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Video 1: The video explains the consequences of rule 11, especially for small manufacturers. (Note: The video still speaks of "Rule 10a". This is how the rule was numbered during the drafting phase of the MDR)

Rule 11 again raises the question of what “physiological processes” are. The MDR does not provide a definition of the term.

Additional information

Read more about vital body functions here . This article provides the missing definition.

2. Which standalone software does NOT fall into class I according to rule 11? a) Definition of medical device

According to the MDR, medical devices are still instruments, apparatus, soft

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