On October 11, 2019, the Medical Device Coordination Group (MDCG) published a guidance document meant to assist medical software manufacturers establish whether their product falls within the scope of Regulations (EU) 2017/745-746, therefore qualifies as medical device software (MDSW).

EUROPEAN UNION: MDCG sheds light on the qualification and classification of software under Regulations (EU) 2017/745 –746

The guidance includes within its scope applications (referred to as “apps”) as well, either operated on a mobile phone, in the cloud or on other platforms.

To simplify the decision process involved in qualifying a software as a medical device, the guidance provides two flowcharts (one for MDR, and one for IVDR) and provides several practical examples of qualification of software used in the healthcare industry. For instance, software that:

  • directly controls a medical device (hardware);
  • provides immediate decision-triggering information;
  • provides support for healthcare professionals

is qualified as medical device software (MDSW) because it has a medical purpose on its own.

Meanwhile, software intended for invoicing or staff planning or electronic patient record systems intended to store, transfer or retrieve electronic patient records/information (with library function) does not qualify as a MDSW because it lacks a medical purpose.

The document also aids stakeholders apply the software classification criteria (“classification rules”) set out in Annex VIII of MDR (and Annex VIII of IVDR) and expands on classification Rule 11 and its implications on other software classification rules.

Further reading:
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR