Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 20, 2019
Date Accepted: Mar 28, 2020
Developing Apps as Medical Devices: An Introduction on Regulatory Affairs for Developers
ABSTRACT
After the Poly Implant Prothese (PIP) scandal in France, the regulations regarding marketing of medical devices were revised. The new Medical Device Regulation (MDR) (EU) 2017/745 was developed and entered into force on the 25th of May 2017. After a transition period of three years it has to be implemented in all EU and EEA member states. The implementation of this regulation bears many changes for medical device development and marketing, which amongst others affect manufacturers of medical device software and mobile apps. The MDR describes qualification and classification of software more detailed than the previously applicable Medical Device Directive (MDD) 93/42/EEC. Especially rule 11 has been introduced to set specific rules for classification of software. Medical device development and marketing is a complex process where manufacturers must keep many regulatory requirements and obligations in mind. This paper thus aims to provide an introduction to regulatory affairs for manufacturers of medical device software and apps. The reader will be given an overview over qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, involvement of notified bodies and the unique device identifier.
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