The EU Commission has completed a targeted evaluation of the MDR and IVDR, on the basis of which a current amendment proposal has been published.
Among other things, adjustments to the classification rules for medical device software are proposed. A concrete draft of the possible new classification rules now exists.
It places software in class I by default, unless criteria for a higher classification apply. This is a reversal of the previous logic, which defined class I via the exclusion principle.
Rule 11, which is the most relevant one for software, can be found in the following extract from the draft:
The changes to Rule 11 of the MDR
The list of possible use cases for the classification rule has also been extended beyond diagnosis and treatment.
It can be assumed, however, that the draft will not pass through the EU legislative process unchanged. Amendments to the Commission draft are likely to be prepared and discussed, and both Parliament and the EU Council of Ministers will negotiate with each other to find a common position.
The draft can be read here: Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices – Public Health