This agreement includes a number of clarifications to the EU Medical Device Regulations. The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15. The text of the draft MDR is at the link provided. The text still needs to have legal editing and translation before it will be published in the Official Journal. This is expected around the end of the year and there will be a three year transition so it will be enforced around the beginning of 2020. A couple of things specific to software in the MDR:
- “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is qualified as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being application is not a medical device. The qualification of software, either as device or accessory, is independent of its location or type of interconnection between the software and a device.”
- One of the risks that must be removed or reduced is “the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts” (Annex I Clause 11.2)
- In the specific requirement for software in Annex I Clause 14.2 the phrase including information security has been added to the list that software must consider and use state of the art principles.
- Software intended to be used with mobile platforms needs to consider specific features of mobile devices.
- A new requirement was added “The manufacturer shall describe minimum requirements on hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended.”
- Requirements for software placement for software.
- Classification rules for software as a medical device (Annex VII section III clause 5.2a.). These appear to be taken from the IMDRF SaMD classification rules.
Agreement can be viewed at this link: EU-mdr-text-06-2016