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, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations 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 (Coordinating 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.@en

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.@en

Background: To assess the extent of between-hospital variation in revision following primary shoulder arthroplasty (SA), both overall and for specific revision indications to guide quality improvement initiatives, and to assess whether revision rates are suitable as quality indicators to reliably rank hospital performance. Methods: All primary SAs performed between 2014 and 2018 were included from the Dutch Arthroplasty Register to examine 1-year revision and all primary SAs performed between 2014 and 2016 for 1- and 3-year revisions. For each hospital, the observed number (O) of revisions was compared with that expected (E) based on case-mix and depicted in funnel plots with 95% control limits to identify outlier hospitals. The rankability (ie, the reliability of ranking hospitals) was calculated as the percentage of total hospital variation due to true between-hospital differences rather than chance and categorized as low (<50%), moderate (50%-75%), and high (>75%). Results: A total of 13,104 primary SAs (87 hospitals) in 2014-2018 were included, of which 7213 were performed between 2014 and 2016. Considerable between-hospital variation was found in 1-year revision in 2014-2016 (median 1.6%, interquartile range 0.0%-3.1%), identifying 3 outlier hospitals having overall significantly more revisions than expected (O/E range 1.9-2.3) and for specific indications (cuff pathology and infection). Results for 2014-2018 were similar. For 3-year revision, 3 outlier hospitals were identified (O/E range 1.7-3.3). Rankabilities for all outcomes were low. Conclusions: Considerable between-hospital variation was observed for 1- and 3-year revision rates following primary SA, where outlier hospitals could be identified based on large differences in revision for specific indications to direct quality improvement initiatives. However, rankabilities were low, meaning that much of the other (smaller) variation in performance could not be detected, rendering revisions unsuitable to rank hospital performances following primary SA.@en