Software and mobile applications that fall under the definition of a medical device or an in-vitro diagnostic medical device are regulated by the respective Directives 93/42/EEC or 98/79/EC. See the texts on Directive 93/42/EEC and Directive 98/79/ECIn the context of borderline cases, the most relevant document is the MEDDEV Guidance 2.1/6, entitled “Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices”.
Released by the Commission services in January 2012 (and updated in July 2016), the document provides practical advice to manufacturers, organisations and public authorities on how to determine when a software falls under the definition of a medical device or of an in-vitro diagnostic medical device. Such criteria also applies to mobile applications.
Please note that addressing qualification and classification issues rely primarily on EU countries.
Should the mobile application be regulated by one of the mentioned directives, the manufacturer, with a view to affix the CE mark, would then be required to follow the appropriate conformity procedure. Such procedure may require, according to the device risk class, an application to one of the notified bodies recognised by the EU. For class I devices, however, a self-assessment is sufficient.
The legislative framework on medical devices has been revised and 2 new regulations will become progressively applicable until 2021 and 2022. The new rules contain dedicated requirements for medical device software, apps, cybersecurity and clinical and performance evaluation.
In the context of borderline cases under the Regulations and further information on medical device software, please refer to guidance on MDCG 2019-11, entitled Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.
