In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity asssessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details ‒ which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE‒MD project (Coordination of Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

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Objective: This cross-sectional study analyzed associations between and determinants for health-related quality of life (HRQoL), fatigue, and societal participation in polytrauma patients. Summary of background data: More polytrauma patients survive their injuries, often resulting in long-term disabilities. HRQoL is therefore an important outcome of trauma care. Fatigue and societal participation may be related to HRQoL. Also, their relation to severe injuries has not been studied to date. Methods: A total of 283 polytrauma patients (injury severity score ! 16) admitted to the Dutch level 1 Trauma Centre West were analyzed. HRQoL was measured by the physical component summary (PCS) and mental component summary (MCS) scores of the SF-36, fatigue by the multidimensional fatigue inventory, and societal participation by the Utrecht scale for evaluation of rehabilitation-participation. Age, sex, comorbidity, injury pattern, injury severity, and time since trauma were analyzed as potential determinants. Results: A total of 122 patients (43%) responded after a median follow-up of 15 (range, 10-23) months after polytrauma; 44% reported reduced physical health (PCS , 45) and 47% reported reduced mental health (MCS , 45). HRQoL was highly correlated with all fatigue and participation subscales. Severe head injury was associated with worse mental health. Female patients reported more general and mental fatigue and were less satisfied with their ability to perform daily activities. Patients with pre-existing comorbidity experienced worse physical health, more fatigue, and reduced societal participation.

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