The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what regulatory approvals it must obtain).

The new rule is therefore relevant to companies and other organisations that sell clinical decision support or physiological monitoring software, including apps, that falls under the MDR’s reworked definitions of “medical device” or “accessory to a medical device.”

The rule, currently labelled 10a in the draft MDR’s seventh annex (“Classification Criteria”), classifies software based on its intended function and the risks associated with its use, such as the danger of misdiagnosis.

  • Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes will be in class IIa or higher. The software will be class III if the decisions it makes could directly or indirectly cause the death or irreversible deterioration of the state of health, while it will be in class IIb if the decisions could directly or indirectly cause “a serious deterioration of the state of health or a surgical intervention.”
  • Software intended to monitor physiological processes will be in class IIa, unless it is intended for monitoring “vital physiological parameters, where the nature of the variation could result in immediate danger to the patient.” In this situation the software will be in class IIb.
  • All other software will be class I.To address concerns about lack of notified body capacity (particularly in relation to standalone software, much of which currently escapes notified body review), the MDR offers a three year transitional period from the date of its entry into force, plus a grandfathering scheme for devices (including software) that are certified under the current rules.

This could mark a significant step up for some companies, in particular those selling standalone software that is currently in Class I under Rule 12 of the Medical Device Directive (MDD), but which could now find itself in Classes IIa or IIb if intended for physiological monitoring, or even Class III if intended for clinical decision support. Resulting obligations of that up-classification include greater notified body oversight, more detailed conformity assessment procedures, and enhanced post-market surveillance requirements.