Regulation of Digital Health Technologies in the European Union

Résumé fourni par la source

If manufacturers of DHTs are able to avoid regulation by marketing them as “lifestyle and well-being” devices, the potential harm to consumers who use DHTs beyond the manufacturer’s intended purpose will not be adequately addressed. There needs to be a framework to re-classify and regulate DHTs based on evidence of actual use. This chapter focuses on how the classification rules and postmarket surveillance system provisions of the EU Medical Devices Regulation (MDR) need to anticipate and address the actual use of DHTs. Courts and regulators have been inconsistent as to how manufacturers are held responsible for known or encouraged “misuse.” By defining a postmarket surveillance requirement for manufacturers to acquire knowledge of actual use, informed regulatory decisions can be made. Actual use information can help establish that the risk caused by a reasonably foreseeable misuse of DHTs was known to the manufacturer in a liability claim should consumers suffer harm from relying on statements or representations, made or implied, when using DHTs to self-manage their health. If data generated by DHTs is used to make regulatory decisions under the 2020 revision of the Good Clinical Practice, the MDR must proactively regulate technologies that have actual impact on consumer health.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.