Is medical device regulatory compliance growing as fast as extended reality to avoid misunderstandings in the future?

Abstract

PurposeEuropean Extended Reality (XR) industry is expected to significantly increase by 2025 with an extreme impact on the Healthcare scenario. Considering that the transition period for the Medical Device Regulation 2017/745 (MDR 2017/745) will end in May 2024, purpose of this study is to assess whether the Medical Device Regulatory Compliance is ready to cope with the inclusion of XR and its possible social and economic impact in the world of medical device software (MDSW).MethodsXR publications patterns were evaluated since MDR 2017/745 release on different databases. European normative about MDSW are consulted, followed by the European Database of Medical Devices (EUDAMED).ResultsThe number of publications on XR have increased since 2017 and healthcare is the third highest-impacted subject area. Specific classes for software have been introduces in the European Nomenclature of Medical Devices (EMDN) and some XR applications have already been registered in EUDAMED classified as MDSW.ConclusionsXR will become intrinsic in everyday medical protocol and guidelines. The establishment of the IEEE Virtual Reality and Augmented Reality Working Group and the statement of VR for remoting surgery as a MDSW in MDCG 2019-11 are demonstration of the necessity of MD regulatory compliance in being able to keep up with the upcoming XR technologies. The Authors agree that the competent authorities should consider intervening in the European Regulative Compliance to cope with the revolution of Phygital in Healthcare and to regulate procedures involving the use of XR in medicine preventing future misunderstanding and criticalities especially for high risk situations.