Brussels, November, 2019 With a little more than a half year to MDR implementation, the EU Medical Device Coordination Group released MDCG 2019-11, a 28 page Guidance on Qualification and Classification on Software in Regulation (EU) 2017/745 MDR and 2017/746 IVDR attempting to add clarity to when software is regulated and how it is to be classified.
The guidance starts with 12 definitions many of which carry over from the MDR or IVDR, and one which has new implications: ‘Software Driving or Influencing the Use of a Device’. Then the guidance provides criteria for qualifying software as Medical Device Software (MDSW) together with a 5 step decision tree. Not all software ends up being subject to CE Mark under MDR or IVDR. For example, software intended only to aggregate population data, provide generic diagnostic or treatment pathways (not directed to individual patients), scientific literature, medical atlases, models and templates as well as software intended only for epidemiological studies or registers. likely does not qualify as MDSW. The second 3 step decision tree guides whether the MDR or IVDR applies. When the intended purpose of the MDSW output data fulfills both MDR and IVDR definitions, a weighting of the data sources based on the significance of the information in relation to fulfilling the intended purpose should be conducted to aid the manufacturer in determining which regulation to apply. Software can also qualify as MDSW regardless of whether it is operating on a mobile device, in the cloud or integrated in a hardware medical device.
Following the second decision tree, the guidance reviews classification scenarios under both MDR and IVDR. Under MDR, the guidance expands on MDR Rule 11 into 3 sub-rules applied depending on intended purpose of the software, attempting to align with the IMDRF framework for risk categorization of software. Similarly, the Guidance discusses in far more detail software intended use attributes and which IVDR Class may apply.
The Guidance concludes with 3 Annexes which provide examples of MDR vs IVDR MDSW, a table for correlating the IMDRF risk categorization scheme and MDR device class, and examples of MDSW, classifications and rules with results which may be far different than that in other regulation schemes. For example, “MDSW intended to perform diagnosis by means of image analysis for making treatment decisions in patients with acute stroke should be classified as class III under Rule 11(a).”
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