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Background: After years in the making, on April 5, 2017, the European Parliament and Council finally adopted Regulation (EU) 2017/745, the new Medical Devices Regulation (MDR), repealing the existing Medical Device Directive (MDD) 93/42/EEC. Though long anticipated, this shift in policy will have strong and lasting effects in the medical devices industry. Objective: This paper focuses specifically on the classification of software as a potential medical device under MDD and MDR and examines whether or not the regulatory framework for health apps has changed substantially and what, if any, impact is to expected. A particular emphasis will be on the issue of classification uncertainty raised by borderline cases such as heart rate monitoring and well-being apps. The paper primarily targets researchers and engineers unfamiliar with regulatory requirements for medical devices and aims to provide a concise, yet accurate, overview of the European regulatory framework. This is of particular relevance as with the exponential growth of fitness and health-related apps, the lines between toys, lifestyle products, and medical devices have increasingly blurred. Methods: The recently published European Medical Device Regulation is analyzed and compared to the preceding MDD. Results: The previous regulatory framework already provided for the possibility of apps to fall under the definition of medical devices, in which case classification rules for active medical devices applied. However, while applicability of the new regulatory framework still hinges on whether the intended purpose is medical or not, the threshold for classifying as a medical device has been considerably lowered due to a broader interpretation of what constitutes a medical purpose. Conclusions: The adoption of the new European regulation on medical devices entails the risk that manufacturers previously unaffected by the medical devices regulatory framework may now unwillingly and unwittingly find themselves in the arena of medical device manufacturing. [JMIR Biomed Eng 2017;2(1):e2]

Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745