Using Device Registries to Generate Clinical Evidence for EU MDR Certification: The Future of Registries

Opportunities in Medical Device Registries and Real-World Evidence

Surgical registries are entering a period of major opportunity, driven by increasing recognition of the value of high‑quality healthcare data, heightened by the COVID‑19 pandemic. Historically, many registries have been limited to short‑term outcomes such as in‑hospital or 30‑day mortality and complications. A key future opportunity lies in capturing long‑term outcomes, which better reflect quality of care and patient safety. One of the strongest opportunities is the systematic capture of implantable medical device data. The UK National Joint Registry (NJR) is presented as an exemplar, having linked detailed implant data with long‑term revision rates to identify early failures of metal‑on‑metal hip prostheses. Similar approaches are now being adopted in other specialties, such as vascular surgery, where late device failures only became apparent years after implantation. Expanding device registries and linking unique device identifiers (UDI) to patient data can enable earlier detection of harm, improve regulatory oversight, and significantly enhance patient safety. Registries also offer financial and sustainability opportunities. Device outcome data are valuable to industry partners, who may support registries in exchange for access to robust, anonymised performance data. This creates potential revenue streams to fund registry maintenance, data quality improvement, and analytical capacity. In the future we may see a “collect once, use often” model: a central, patient‑identifiable device database linked to multiple registries for audit, research, and surveillance.  

A major future opportunity lies in the integration of registries with electronic medical records (EMRs) and other linked datasets, enabling access to vast quantities of longitudinal, population‑level data. Population‑wide data linkage, already well‑established in Scandinavian countries and rapidly accelerated in the UK during COVID‑19, allows registries to move beyond isolated datasets. Linking primary care, hospital episodes, mortality data, and registries within trusted research environments enables richer longitudinal analyses and large‑scale observational research, particularly for cardiovascular and surgical outcomes. As digitisation and computing power increase, registries have proliferated in size, scope, and influence across clinical care, research, and policy. Such integration allows registries to move beyond passive surveillance towards real‑time evaluation of clinical care and health system performance. Large, linked datasets can support health‑economic analyses, long‑term outcome tracking, and assessment of real‑world effectiveness that are often impractical in traditional trials.  

Another important opportunity is the growth of registry‑based randomised controlled trials (RCTs). These studies retain the methodological strengths of RCTs while dramatically reducing cost and complexity by using existing registry infrastructure for patient recruitment, follow‑up, and outcome collection. High‑profile examples such as the TASTE trial demonstrate that registry‑based RCTs can achieve high enrolment, strong external validity, and substantial cost savings, positioning them as a potentially transformative research paradigm. Other surgical examples, such as hernia trials in the USA, demonstrate high follow‑up rates and the ability to assess clinically meaningful and cost‑effectiveness outcomes, including patient‑reported outcomes. 

The momentum towards global and multinational registries, which is a positive development, either through harmonisation of existing national datasets or creation of new international registries. Initiatives such as the International Consortium of Orthopaedic Registries aim to standardise data collection, enable cross‑country comparisons, and improve the generalisability of findings. Expanding registries into low‑ and  middle‑income countries is presented as a particularly important opportunity for addressing global disparities and informing trauma and surgical care worldwide. Emerging big data analytics and machine‑learning applications represent another future direction. When applied to large, high‑quality  registry datasets, machine learning algorithms may support predictive modelling, clinical decision support, and personalised care. Registries are positioned as foundational data sources for these technologies, particularly when combined with EMR data and natural language processing.

There is an increasing regulatory importance of registries; under the MDR, manufacturers are required to conduct continuous post‑market surveillance, and registries provide access to large, unselected populations with longer follow‑up than traditional pre‑market trials. Real‑world registry data can detect rare adverse events, benchmark device performance, and enable earlier identification of poorly performing implants, as exemplified historically by metal‑on‑metal hip prostheses and coronary stents. Registries also support lifecycle evaluation, rather than one‑off assessments of device safety. Mature registries with sustained follow‑up can generate evidence that spans early adoption, widespread clinical use, and long‑term outcomes. When well‑designed, registries allow continuous performance monitoring and cross‑device comparisons that are essential for regulatory decision‑making  and patient safety surveillance. Registry utility could be enhanced through greater harmonisation and standardisation. Reaching consensus on a core set of structural, methodological, and outcome-reporting standards would significantly improve comparability, reliability, and regulatory usability. Enhanced linkage with other data sources, such as national health datasets and vigilance systems, could further strengthen registries as PMCF tools. 

Challenges Facing Device Registries in MDR Compliance

Despite these opportunities, significant challenges remain. Data completeness and case ascertainment are recurring concerns, requiring sustained professional engagement, adequate resources, and mandatory data entry. Governance and transparency also pose challenges, particularly regarding surgeon‑level outcome reporting. There is recognition that surgical outcomes reported at unit- or team‑level reflect shared decision making. As a result, there is a shift towards unit‑ or hospital‑level public reporting in some registries; balancing transparency with fairness; there are concerns that surgeon-level reporting can result in risk‑averse behaviour, for example in patient selection.  

Data quality remains the central limitation of registries. Variability in data completeness, accuracy, outcome definitions, and follow‑up can introduce bias and undermine validity. Passive follow‑up and lack of adjudication often result in under‑reporting of adverse events compared with formal clinical trials. Missing data, inconsistent enrolment, and registry designs not aligned with the research question further compromise reliability. Assessing registry quality is itself challenging, as there is no widely accepted quality assessment tool equivalent to those used for RCTs. Users must critically evaluate whether a registry is appropriate for the question asked, whether the population is representative, and whether internal and external validity are adequate.  

Among eligible cardiovascular and orthopaedic registries analysed, reporting of key structural and methodological quality indicators was highly variable. On average, cardiovascular registries reported only one‑third of the predefined quality items, while orthopaedic registries performed better but still inconsistently. Critical elements, such as patient‑level data completeness, methods for handling missing data, and standardised outcome definitions were frequently absent or poorly documented. A particular concern is the lack of standardised reporting for safety and performance outcomes, including outlier detection. Few registries reported formal device outlier analyses, and among those that did, definitions and methods varied widely. This limits the ability of regulators to compare evidence across registries or rely on them for consistent PMCF evaluations. Governance and data quality also present ongoing challenges. Many registries provide insufficient transparency regarding funding, data access, privacy protections, or quality‑assurance processes. Without clear governance structures and robust data validation, confidence in registry‑derived evidence for regulatory purposes could remain constrained.  

Notified Bodies Perspective on the Future of Registries

From the perspective of an EU Notified Body, the following represent key opportunities for registry development to better align with the objectives of the Medical Device Regulation (MDR): 

• Common Specifications (CS): Alignment of registry design and the collection of safety and performance outcome data with applicable device common specifications, thereby supporting and streamlining conformity assessment activities.
• EMDN codes: Establishment of EU registries structured around European Medical Device Nomenclature (EMDN) codes for implantable and Class III devicesinall member states where these devices are placed on the market, for example at the third EMDN level (such as Q0103 Surgical Dental Devices, P0704 Vascular Prosthesis, or P0903 Wrist Prosthesis) with sub-registires at more granular EMDN levels (e.g. P01020101 DENTAL IMPLANTS). 
• Regulatory access to registry data: Provision of controlled access to detailed registry data for relevant regulatory authorities, including Notified Bodies (for devices they certify) and Competent Authorities (for devices placed on the market within the relevant Member State),with linkage to certificate and UDI information and established criteria and processes for devices that are negatively trending and / or reaching outlier status. 
• Well‑Established Technologies (WET): Prioritisation of registry development for WET devices(Article 52 of the MDR) where published clinical evidence is limited or absent. 
• ISO 14155: Alignment of registry design with the principles of ISO 14155, including patient protection, scientific validity, clearly defined roles and responsibilities, ethical oversight, informed consent, and robust systems for documentation and monitoring.

The Future of Medical Device Registries and MDR

Device and surgical registries are entering a pivotal phase of development, with the potential to transform patient safety, clinical care, research, and regulatory oversight. Advances in data capture, linkage, and analytics, particularly around implantable medical devices and long‑term outcomes, offer powerful mechanisms to detect harm earlier, evaluate real‑world effectiveness, and support lifecycle assessment of medical technologies. Integration with electronic medical records, expansion of multinational registries, and the growth of registry‑based randomised trials further enhance the strategic value of registries as core health system infrastructure. However, these opportunities will only be realised if persistent challenges around data quality, completeness, governance, and standardisation are addressed. From a regulatory perspective, closer alignment with MDR requirements, through use of common specifications, EMDN‑based structures, UDI linkage, and controlled regulatory access, would substantially strengthen registry utility for post‑market surveillance and conformity assessment. Well‑governed, high‑quality registries should therefore be viewed not as optional adjuncts, but as essential components of modern, data‑driven medical device regulation and patient safety systems. 

Read more about medical device registries in Part 1: Using Device Registries to Generate Clinical Evidence for EU MDR Certification

Read more about specific medical device examples in Part 2: Using Device Registries to Generate Clinical Evidence for EU MDR Certification: Specific Devices

References

• Boyle J. R. (2021). Future of surgical registries. The British journal of surgery, 108(7), 740–741. https://doi.org/10.1093/bjs/znab176  
• European Commission. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (2017/745) https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng  
• European Commission – European Medical Device Nomenclature (EMDN) https://webgate.ec.europa.eu/dyna2/emdn  
• Hoogervorst, L. A., Geurkink, T. H., Lübbeke, A., Buccheri, S., Schoones, J. W., Torre, M., Laricchiuta, P., Piscoi, P., Pedersen, A. B., Gale, C. P., Smith, J. A., Maggioni, A. P., James, S., Fraser, A. G., Nelissen, R. G. H. H., & Marang-van de Mheen, P. J. (2023). Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review. International journal of health policy and management, 12, 7648. https://doi.org/10.34172/ijhpm.2023.7648  
• International Organization for Standardization. (2026). Clinical investigation of medical devices for human subjects — Good clinical practice (ISO Standard No. 14155:2026) https://www.iso.org/standard/83968.html  
• Rubinger, L., Ekhtiari, S., Gazendam, A., & Bhandari, M. (2023). Registries: Big data, bigger problems? Injury, 54, S39-S42. https://doi.org/10.1016/j.injury.2021.12.016 

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