Using Device Registries to Generate Clinical Evidence for EU MDR Certification

Introduction 

The European Union Medical Device Regulation, EU MDR 2017/745 (European Commission, 2017), includes a significantly strengthened framework for medical device safety and performance evaluation, and post-market surveillance (PMS). Registries as structured systems for collecting real-world clinical data are increasingly recognised as high value sources of clinical evidence that can be utilised for the conformity assessment process. The MDR explicitly encourages the establishment of device registries and databanks to support vigilance, traceability, post-market clinical follow-up (PMCF), and ongoing benefit-risk evaluation (Article 108). Annex VII also outlines that Notified Bodies should consider registry data submitted by the manufacturer for the renewal of MDR certificates.  

Although registries existed long before the MDR, their use is often fragmented, inconsistent, or limited to specific clinical communities (e.g. joint replacement implants). Under the MDR, they now carry far greater regulatory relevance because manufacturers must provide continuous clinical evidence throughout the device lifetime, including real-world safety and performance  data. For many devices, especially implants, well-established technologies, orphan devices, and products with limited premarket evidence, registry data can be used to demonstrate compliance with the General Safety and Performance Requirements (Annex I – GSPRs). 

MDR Requirements for Clinical Evidence and PMS  

The MDR requires a structured, transparent and robust clinical evaluation process, ideally including real-world data sources. Article 61 requires that manufacturers demonstrate conformity with the GSPRs using sufficient clinical evidence proportional to the risk classification and novelty of the device. Registry data are explicitly recognised as valid clinical evidence sources. 

If available, manufacturers must integrate registry data into: 

• Clinical Evaluation Reports – CERs (European Commission, 2016) 

• Post-Market Clinical Follow-Up (PMCF) activities, Annex XIV (Medical Device Coordination Group, 2020a, 2020b, 2020c) 

• Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices (Medical Device Coordination Group, 2022) 

• Summary of safety and clinical performance – SSCP (Medical Device Coordination Group, 2019) 

• Post market surveillance (PMS), safety signal detection and trend analysis (Medical Device Coordination Group, 2025 and Badnjević, 2022) 

• Risk management updates (International Organisation for Standardisation, 2019) 

• ISO 13485 quality management system (QMS) processes including Design Validation and Feedback – clauses 7.3.7 and 8.2.1 respectively (International Organisation for Standardisation, 2016) 

Figure 1 – Hierarchy showing relationship between registry data to other process in the manufacturers QMS. Output and updates to these processes feed into documentation updates over the device lifetime such as CER, SSCP and PSUR.

Registries can be considered a high-quality clinical data (Rank 3 from Appendix III of MDCG 2020-09 in terms of level of evidence) collection system in the post-market phase to support clinical benefits (Medical Device Coordination Group, 2020c) with real-world data for MDR submissions to Notified Bodies and other global regulators (Food and Drug Administration, 2025 and Dang, 2023). Registries can support these obligations by providing large-scale, longitudinal, real–world datasets, which may be impossible to acquire through conventional clinical studies alone (Sedrakyan, 2022, Beit Ner, 2022, Rubinger, 2023 and Doherty, 2023). 

ISO 14155 and Its Relevance to Registries 

 ISO 14155:2020 (International Organisation for Standardisation, 2020) provides the international standard for Good Clinical Practice (GCP) in medical device clinical investigations. While the standard mainly governs interventional clinical investigations, many of its principles apply directly to registry-based research, registry-embedded RCTs (Doherty, 2023), or PMCF activities conducted within registries. Registries are also outlined in Annex I of ISO 14155 as an integral part of the post-market clinical development stage.

According to ISO 14155, clinical studies must:  

• Protect the rights, safety, and wellbeing of human subjects 
• Ensure scientific validity and credibility of results 
• Clearly define responsibilities of sponsors, investigators, and monitors 
• Establish proper protocols, data quality systems, and monitoring  

Registries that aim to support MDR certification should therefore reflect ISO 14155 principles where applicable, especially regarding data integrity, ethics approvals, informed consent, monitoring procedures, endpoint definitions, and documentation. 

Types and Functions of Device Registries

The literature identifies multiple registry types: disease-based, procedure-based, pathology-specific, product-focused, or hybrid ecosystems linking multiple datasets. Examples include joint arthroplasty (Beit Ner, 2022 and Hallstrom, 2022), cardiovascular (Batra, 2023, Hoogervorst, 2023 and Malenka, 2022), spine (Quigley, 2023 and Pascucci, 2023), neurology (Lee, 2021) and dental implant (Berge, 2025 and Naemi, 2021) registries. These device-specific registries will be explored in greater detail in Part 2 of this article series. 

Registries serve several regulatory-relevant functions:

• Collecting real-world performance data (Dang, 2023) 
• Monitoring adverse events and revisions (Hoogervorst, 2023) 
• Identifying early device failures (Beit Ner, 2022) 
• Benchmarking implants, techniques, centres, and operators (Hallstrom, 2022) 
• Supporting RWE-based decision-making at system and regulatory levels (Dang, 2023)

The MDR’s emphasis on continuous lifetime evidence makes these functions indispensable as a clinical data source for MDR certification. 

Strengths of Using Registry Data for MDR Evidence 

Registries have several advantages over traditional clinical studies: 

• Large, diverse populations enabling generalizable conclusions (Rubinger, 2023) often exceeding patient numbers in clinical investigations and post-market studies 
• Long-term follow-up extending far beyond typical premarket trials (Rubinger, 2023) 
• Cost efficiency (Giori, 2021), also illustrated by registry-based RCTs (e.g., TASTE trial – Rubinger, 2023)   
• Detection of rare events (Doherty, 2023) and device failures (Beit Ner, 2022), e.g. metal-on-metal hips, ASR recall  
• Integration with EHRs (Giori, 2021), PROMs (Boyle, 2021), and UDI systems 
• High external validity, reflecting real-world clinical practice (Dang, 2023) 
• Comparisons between countries / markets 
• Collection and stratification of data on device variants / sub-variants  

These characteristics align well with MDR expectations for collecting clinical data, PMCF and ongoing risk-benefit evaluation. 

Limitations and Challenges  

Despite their value, registries also face challenges that must be considered if the data is used to support MDR certification: 

• Heterogeneity in data collection (Quigley, 2023), variables, outcomes, and definitions across Europe (Rubinger, 2023) 
• Incomplete coverage (Rubinger, 2023) and data quality gaps, particularly in cardiovascular registries (Hoogervorst, 2023) 
• Passive follow-up underestimates adverse events (Rubinger, 2023) and a lag between safety events and identification and actions by the registry 
• Lack of standardised outlier definitions across registries (Hoogervorst, 2023) 
• Variable enforcement of data entry (Rubinger, 2023) 
• Potential selection, reporting, and measurement biases (Dang, 2023 and Doherty, 2023) 
• Funding dependence and the risk of conflicts of interest in industry-supported registries (MedTech Europe, 2017) 
• Small number effects which can lead to aspects such as false positives and / or low statistical power 

These limitations may affect the reliability and regulatory acceptability of registry data and provide areas of focus for the strategic development of future registries (covered further in Part 3 of this article series). 

Quality Requirements for MDR Use of Registry Data 

For registry data to meaningfully support conformity assessment, manufacturers should evaluate the registry according to key criteria identified in the literature and regulatory guidance: 

• Coverage – ideally ≥95% patient/procedure inclusion, per IMDRF (Hoogervorst, 2023) 
• Data completeness – e.g. a variable will only be analysed if completeness is ≥95% (Hoogervorst, 2023) 
• Accuracy and validation procedures – audits, monitoring, UDI traceability (European Commission, 2015) 
• Consistency of definitions, outcomes, and timepoints (MedTech Europe, 2017) 
• Robust governance and data protection mechanisms – GDPR (MedTech Europe, 2017) 
• Links to other datasets – EHR, national registries, mortality data (Gliklich, 2014) 

High-quality registries could increasingly serve as an essential component of MDR clinical evidence strategies. 

Notified Body Experience of Registry Data

Within the Orthopaedic team at BSI, there is extensive experience in evaluating registry data to support MDR certification. This includes input from clinicians with previous direct involvement in the UK National Joint Registry (NJR). Based on our experience with the NJR and other international joint replacement registries, several recurring considerations commonly arise: 

• PROMs data is often limited. While survival rates and reasons for revision are usually well captured as safety outcomes, there is frequently far less reporting of patientreported outcome measures (PROMs), which are key indicators of device performance. 
• Data stratification requires careful balance. Differentiating between implant variants and indications is essential, but excessive granularity can reduce the statistical power and scientific robustness of the analysis. 
• Predicting early sales and registry uptake is challenging. For new products undergoing initial MDR certification, manufacturers may struggle to anticipate market adoption in individual countries making it difficult to forecast how much registry data will be available in the early years. 
• Manufacturers often see deeper insights than regulators. Many registry systems provide manufacturers with access portals containing more detailed, realtime data on their devices than what appears in public reports or is accessible to regulators, creating an important dynamic in evidence interpretation. 

Conclusions

As the MDR continues to reshape the regulatory landscape for medical devices, registries have evolved from optional data collection resource into critical pillars of lifecycle evidence generation. Their ability to provide comprehensive, longitudinal, real‑world data makes them uniquely positioned to support continuous assessment of safety, performance, and clinical outcomes – core expectations within the MDR framework. While challenges remain, particularly regarding data quality, harmonisation, governance, and consistent methodology, well‑designed registries that align with recognised standards and principles are increasingly becoming essential tools for manufacturers seeking to demonstrate ongoing compliance with the GSPRs. By integrating registry evidence across CERs, PMCF, PMS, and broader risk‑management processes, manufacturers can not only meet regulatory obligations but also contribute to improved patient safety, better device transparency, and higher‑quality clinical care across Europe and other jurisdictions. 

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