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Feature Articles
9 July 2025

From data to decisions: Real-world evidence for medical devices in the US and the EU

Author(s)

This article highlights the similarities and differences in the acceptance of real-world evidence (RWE) as clinical data for medical devices in the US and the EU. It will explore the industry perspective on the use of RWE in the US and the notified body perspective on accepting RWE as clinical evidence. The article includes four anonymized case studies in which RWE collected by postmarket clinical follow-up (PMCF) activities was accepted by a notified body in support of CE marking.
 
Keywords – FDA, EU MDR, medical devices, notified bodies, real-world evidence
 
Introduction and background
The regulation of medical devices is critical to ensuring patient safety and broad access to innovative, state-of-the-art medical technology. However, the US and EU approaches to regulation differ.
 
The US: A centralized and premarket-focused approach
The US system, overseen by the US Food and Drug Administration (FDA), has its roots in the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938.1 Early regulation was minimal, focusing primarily on labeling and adulteration. However, a series of tragic incidents involving faulty medical devices, such as the Dalkon Shield intrauterine device in the 1970s, spurred significant changes. The 1976 Medical Device Amendments2 significantly expanded the FDA's authority, introducing a risk-based classification system for devices and requiring premarket approval for higher-risk devices. This premarket emphasis reflected a desire to prevent harm before it occurred, prioritizing safety and efficacy through rigorous testing and clinical trials before a device reached the market. Further legislation, like the Safe Medical Devices Act of 1990,3 strengthened postmarket surveillance, requiring reporting of adverse events and giving the FDA the power to recall faulty devices.
 
The EU: A decentralized and postmarket-focused system
The EU initially established medical device regulation in the early 1990s with the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive.4,5 In contrast to the US, the EU's approach is more decentralized and relies on a network of notified bodies, which are independent organizations designated by the EU member states to assess the conformity of medical devices with EU law. The EU's initial directives focused on harmonizing essential safety and performance requirements across member states and allowing manufacturers to demonstrate compliance through various routes, including self-certification for lower-risk devices. This approach aimed to facilitate the free movement of goods within the single market while ensuring patient safety. While the EU system has historically placed less emphasis on premarket scrutiny, the introduction in 2017 of the EU Medical Device Regulation (EU MDR), also known as Regulation (EU) 2017/745, marked a shift toward stricter clinical data requirements and postmarket surveillance.6 Like in the US, this shift was driven by serious safety issues, particularly the Poly Implant Prothèse breast implants and metal-on-metal hip replacements, and a desire to strengthen patient safety and oversight.7
 
Key differences in US and EU regulations
There are some key differences between the regulations in the US and the EU:
 
  • Risk classification – Both systems use risk-based classifications, but the EU's system is generally considered more stringent, particularly for higher-risk devices.
  • Clinical evidence – The US and the EU emphasize clinical data to demonstrate the device's safety and performance. However, the US system allows applicants to more easily leverage clinical data from a predicate device via a 510(k) clearance to demonstrate equivalence compared to the EU MDR.
  • Postmarket surveillance – Both systems require postmarket surveillance, but the EU MDR mandates more proactive and systematic monitoring after the device is placed on the market.
 
The variation between the two systems reflects different underlying priorities shaped by cultural and historical factors. The US system is characterized by an emphasis on individual entrepreneurship and market-based policies, whereas the EU framework focuses more on collective welfare and regulatory consistency among its member states, incorporating precautionary approaches in its decision-making processes.8
 
These contrasting approaches are also reflected in the difference in how real-world data (RWD) and RWE are considered clinical evidence in the US and the EU. RWD, in the context of medical devices, refers to information collected from various sources outside the confines of traditional clinical studies. This encompasses data derived from routine use and experience with medical devices in real-world settings obtained through electronic health records, patient registries, claims data, and even data from wearable devices or mobile health applications. Unlike clinical investigation data, RWD offer a glimpse into the broader, more diverse patient population interacting with medical devices, potentially revealing valuable insights into device effectiveness (performance), safety, and long-term outcomes in a naturalistic setting.
 
The FDA has progressively embraced the potential of RWD and RWE derived from it, acknowledging their ability to inform regulatory decision making throughout the total product lifecycle of a medical device. The FDA, while recognizing the potential of RWD, places a strong emphasis on data quality and relevance. Data sources should ideally be well established and of high quality, such as those derived from electronic health records, patient registries, and claims databases. When generating RWE from RWD, rigorous study designs and appropriate methodologies are essential to minimize bias and ensure the validity of the evidence.
 
In the EU, the MDR similarly underscores the role of RWD within its framework. Postmarket surveillance, a core component of the EU MDR, relies on RWD to facilitate continuous monitoring of device performance, proactively identify safety issues, and assess long-term clinical effectiveness. Furthermore, RWD can be incorporated into the ongoing clinical evaluation of medical devices, providing real-world insights to update clinical evidence and maintain regulatory compliance.
 
The EU, with the General Data Protection Regulation (GDPR), and the US, with the Health Insurance Portability and Accountability Act (HIPAA) in 1996, have enacted strict regulations to ensure patient data safety.9,10 However, the EU MDR also strongly emphasizes data protection and privacy, mandating strict adherence to the GDPR when handling RWD. Transparency is also paramount, with manufacturers expected to provide comprehensive information on data sources, collection methods, and analysis techniques when submitting RWD in regulatory dossiers.
 
RWE and postapproval studies in the US
The FDA has long recognized the value of alternative sources of clinical data in fulfilling its obligations to ensure the safety and effectiveness of medical devices marketed in the US. Although the FDA reviews premarket data to determine whether a device meets the statutory standards for market clearance, it also acknowledges that some risks and benefits of a device may not be fully known until it is used in real-world settings. As an alternative to premarket protocol-driven clinical investigations (i.e., investigational device exemption studies), the FDA has accepted the potential value of clinical data collected outside of an investigational protocol for quite some time. Examples of such are registries and electronic medical records (EMRs).11
 
Therefore, when additional risks are identified, specifically those that arise after the device is on the market, the FDA has the authority and the responsibility to request the collection and examination of data collected in the postmarket or real-world setting. The FDA has various tools available to ensure its specific questions are answered. These include convening an advisory committee, requiring a postapproval study at the time of marketing authorization (PMA approval), and issuing 522 orders. The FDA’s goal in each approach is to assess the totality of evidence, focusing primarily on evidence generated in the real-world setting.
 
The FDA may choose to convene an advisory committee to assess available data indicating safety concerns. Advisory committee meetings are governed by a variety of regulations, for which there are corresponding guidance documents.12 Recent examples of devices requiring advisory committee meetings include devices for peripheral vascular disease that utilize paclitaxel and endograft devices to treat aortic aneurysms.13,14 For both devices, data collected under IDE protocols were examined, but it was the assessment and presentation of RWE that ultimately affected the regulatory decisions.
 
The FDA may require a postapproval study for specific devices as a condition of market clearance. These studies are intended to evaluate the continued safety and effectiveness of the device or to collect additional information that was not available at the time of premarket review. A common postapproval study requirement is additional longer-term follow-up on patients with a Class III implanted device. Postapproval data collection requirements are also common for devices approved under the Humanitarian Device Exemption program. The FDA reviews and monitors these studies and may take regulatory actions based on the results. A public database of the status of postapproval studies is available.15
 
In addition to required postapproval studies, Section 522 of the FD&C Act gives the FDA the power to order medical device manufacturers to conduct postmarket surveillance studies for a Class II or Class III device that meets one or more of the following criteria:
 
  • Its failure would be reasonably likely to have serious adverse health consequences,
  • It is expected to have significant use in pediatric populations,
  • It is intended to be implanted in the body for more than one year, and/or
  • It is intended to be a life-sustaining or life-supporting device used outside a device user facility.
 
The FDA issues 522 orders when it identifies a need to address a serious safety issue, a new use of an existing device, or a gap in scientific knowledge. These orders can be issued at any time during the marketing lifetime of the medical device. The FDA monitors the progress and results of the studies through a publicly available database16 and may take regulatory actions based on the findings, such as requiring labeling changes, issuing safety communications, or initiating recalls.
 
Notably, although they are conducted in a postmarket setting, both postapproval and 522 order studies result in a protocol-driven clinical study activity conducted by the medical device manufacturer. The implication is that the study is designed to answer clinical questions of interest but may fail to identify other safety or effectiveness concerns that may manifest in a real-world setting. Due to this perceived weakness in required postapproval and 522 order studies, the FDA has acknowledged that RWD can often provide needed evidence.
 
The FDA has accepted various sources of RWE for some time.11 In addition, the FDA also provides guidance and standards for the use of RWE in regulatory submissions. In fulfilling its obligations to ensure the safety and effectiveness of medical devices marketed in the US, the FDA has supported various initiatives to further the development and use of RWE. An initial 2017 guidance on using RWE to support regulatory decision making for medical devices highlights the FDA’s interest in the relevance and reliability of real-world evidence.17 A revision to that guidance is currently in a draft state and is poised to offer additional information regarding the FDA’s expectations around assessing relevance and reliability. In addition, the methodology for collecting RWD, along with protocol and report content, will also be addressed.
 
In addition, the FDA has provided funding to the Medical Device Innovation Consortium to establish the National Evaluation System for Health Technology (NEST) to facilitate the development and use of RWE for medical devices. NEST’s mission states, “The NEST community is passionately committed to transforming the way medical device technologies are tested, approved, and monitored.”18 This is accomplished through a “coordinating center offering services that catalyze real-world evidence (RWE) generation for medical device and health technology research sponsors.”
 
In summary, the FDA has a number of tools available to ensure the safety and effectiveness of medical devices on the market. Provided that the RWD are both relevant and reliable19 in their ability to answer questions of interest, the FDA has shown that it is willing to engage medical device manufacturers in assessing RWE for regulatory decision making.
 
RWE in EU postmarket clinical evidence strategies
The European Commission also recognizes that the risks and benefits of a medical device may not be fully known until it is used in real-world settings.20 As such, it enacted the EU MDR, which increases the regulatory scrutiny of safety and performance over the lifetime of a medical device.6 Regarding clinical evaluation, the EU MDR codifies more stringent surveillance obligations, including the requirement for continuous PMCF.
 
Through PMCF, manufacturers are responsible for proactively collecting and evaluating clinical data on the use of commercially available devices on the EU market through the following actions: confirming the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime; identifying previously unknown side-effects and monitoring the identified side-effects and contraindications; identifying and analyzing emergent risks on the basis of factual evidence; ensuring the continued acceptability of the benefit-risk ratio; and identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.6
 
The Medical Device Coordination Group (MDCG) created guidance documents to further describe the expectations of clinical evaluation under EU MDR. MDCG 2020-6, a guidance document for devices previously CE marked under the directives, outlines the lifecycle aspects of clinical evaluation for determining whether a device is safe and performs as intended by the manufacturer.21 It explains that through a qualified assessment of the current state of the art, the acceptability of the benefit-risk ratio based on sufficient clinical evidence, and the incorporation of postmarket surveillance data (including PMCF), conformity with relevant GSPRs may be demonstrated. The device manufacturer must have sufficient clinical evidence, including, at a minimum, consideration of each indication for use/intended patient population, the breadth of product sizes and configurations, possible safety and performance signals, and published occurrences of off-label use.
 
There is no one-size-fits-all approach to gathering sufficient clinical data, and the EU MDR allows for the use of multiple clinical data sources if scientifically valid methodologies are used to generate clinical data. RWE, in particular, can be a powerful source of device safety and performance information if the RWD from which the RWE is derived are relevant and reliable. While the EU MDR does not specifically mention RWE, MDCG 2020-7 references its analyses as a valid type of PMCF strategy if the RWD from which these analyses are based come from reliable sources and are of sufficient quality.22 Presently, there are no European guidelines on RWD quality standards; however, following good clinical practice principles is expected, as with any clinical data source. As previously mentioned, the FDA has published guidance documents on data quality and good clinical practice considerations specific to RWD studies on medical devices. These documents provide scientific and instructional information that is applicable beyond the US.23
 
In addition, the European Medicines Agency has recently published guidances pertaining to the use of RWD in the support of pharmaceuticals.24,25 While medical devices have unique challenges in need of solutions (e.g., limited capture of unique device identification in health systems, challenges of relevancy when using common structured datasets such as claims data), the regulatory expectations and examples from these guidances may provide insight.
 
Similarly to NEST, Europe has also recently invested in a public-private partnership to develop solutions for the use of RWE in the healthcare decision making of medical devices. This partnership, the Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IDERHA), is funded by the EU’s Innovative Health Initiative and seeks to drive development of guidelines and policies for the acceptability of RWD for regulatory and health technology assessment decision making in Europe.26 Though there is currently a lack of EU-specific RWD guidance for medical devices, collaborative efforts such as IDERHA will hopefully fill this gap quickly.
 
Lack of guidance aside, RWD sources are increasingly used in EU clinical evidence strategies. In a 2024 study about using RWD for PMCF was required to provide long-term safety and performance data on implantable embolization coils to meet EU MDR requirements.27 Notably, the EMRs used in this study linked patients with the model numbers of the coils within their database, allowing for the connection to the patient's clinical encounter. This connection between patient encounters and device model numbers was necessary to both identify treated patients and longitudinally access patient data from the day of the procedure through all available follow-ups (i.e., patient encounters occurring after treatment). The study authors reported that the study design provided a comprehensive and resource-effective strategy to assess the long-term safety and performance of the manufacturer’s embolization coils, and the methods were sensitive enough to uncover the expected rate of performance failures and adverse events from the structured and unstructured data found in patient EMRs.
 
When considering an RWE approach for clinical evidence, many companies claim to provide comprehensive RWD on medical devices, yet few currently meet the needs of manufacturers. Beyond demonstrating RWD relevance and reliability, companies must be able to:
 
  • Link specific medical device model numbers to specific patients;
  • Provide comprehensive access to unstructured data containing key information regarding the procedure and patient outcomes;
  • Longitudinally track patients through their care continuum; and/or
  • Effectively extract key data elements from patients’ EMRs that inform device safety and performance.
 
Finally, each study must include an assessment of transferability justifying how the data derived from the studied cohort sufficiently relates to the intended population commercially treated with the device. The assessment must also effectively justify the quality and protection of the dataset. With careful planning and access to fit-for-purpose RWD, manufacturers can better sustainably meet EU MDR requirements.
 
A notified body perspective on RWE
Notified bodies acknowledge the benefits of using clinical data derived from RWD-based activities while recognizing the limitations. Since the implementation of the EU MDR, notified bodies have seen an increase in the number of legacy device applications that use RWD. In these cases, RWD gathered via surveys and/or data collection systems, such as registries, are typically used to supplement clinical data derived from other sources to generate sufficient clinical evidence to demonstrate conformity to the EU MDR. Notified bodies have also seen an increase in specific PMCF activities based on RWD studies to demonstrate compliance with Annex XIV, Part B.
 
Regardless of whether a manufacturer presents RWD as a source of clinical evidence to demonstrate conformity to the EU MDR or as part of the manufacturer PMCF strategy in accordance with Annex XIV, Part B, the notified body’s acceptance of RWD is assessed on a case-by-case basis and is very much dependent on the risk class of the medical device and the totality of the clinical evidence provided for the device.
 
When assessing the suitability and adequacy of clinical RWD, the notified body will consider the proposed research question, study/survey objectives, the type and level of generated clinical evidence, methodology including study population geographics and sample size including statistical justifications as appropriate, the rationale for and appropriateness of the selected methods (e.g., national or company sponsored registries, patient or user level survey, electronic health records), study outcomes/endpoints and acceptance criteria, quality and reliability of the collected data, as well as any other details which can impact the acceptability of the resulting clinical evidence.
 
The notified body expects a critical evaluation of the RWD, both favorable and unfavorable. Manufacturers are expected to analyze, interpret, and discuss data in the context of the device’s intended purpose, patient population, state of the art, risk management, and other relevant factors so that reliable and statistically valid conclusions can be reached. When discussing the results, the notified body expects that the findings are related back to the study/survey objectives and that any data points outside of the predefined acceptance criteria are addressed.
 
The conclusions should indicate if the clinical data generated from the RWD study/survey are of sufficient quality, quantity, and reliability to support the specific research questions and objectives it was designed to address, and if further studies are required. Adverse events, whether known or newly identified, should be compared against the device's risk management. If needed, appropriate actions should be taken to mitigate any potentially negative effects. Four case studies are presented, each of which provides a general overview of how manufacturers of a range of medical devices made use of RWD. In accordance with MDR Annex VII Section 1.3 and to protect the confidentiality of the information which has come into the possession of the notified body during the performance of conformity assessment, each case study has been anonymized.
 
Case study A: Medical device registry review for a Class III total knee replacement
Aim of specific PMCF activity
The total knee replacement was a legacy device originally certified under the MDD. The manufacturer presented the notified body with sufficient clinical data from clinical literature, postmarket surveillance (PMS), and clinical studies to support the safety and performance objectives. However, limited data to support the 10-year device lifetime were available. In addition, the device was either not sold in countries with national joint registries, or the existing registries did not provide sufficient clinical evidence specific to the device. The activity aimed to collect clinical data over the device’s lifetime through real-world use collected through device-specific registries.
 
Objectives
  • Confirm the safety and performance of all device variants for all indications throughout the expected lifetime.
  • Identify and analyze emergent risks through real-world usage of the device.
  • Ensure the continued acceptability of the benefit-risk ratio.
  • Identify possible systematic misuse or off-label use of the device.
 
Methodology
The manufacturer worked with a commercial partner that provided a registry software platform to collect routine clinical care data. Ten different sites were recruited to contribute to data collection, and the manufacturer justified the relevance of these sites to the patient population. Patient demographics, survivorship, functional outcomes, and adverse events were collected. The manufacturer described the registry design and addressed data quality management, including validation of systems, quality control, and data security. A protocol outlining specific information relating to the PMCF activity objectives, recruitment procedures (including exclusion/inclusion criteria), statistical considerations, and data analysis was provided.
 
Limitations
Data were only available from specific sites participating in the data collection and may not have been generalizable to the entire patient population. Data quality management was outsourced and not under the direct control of the manufacturer. Patient outcomes were generally not reported at the 10-year time point, and the main clinical benefit of reduced pain and improved function could not be evaluated.
 
Timelines
Annual interim reporting is performed until sufficient clinical evidence, as defined in the clinical evaluation and PMCF plan, is captured for the device's lifetime.
 
Case study B: PMCF survey for Class III implantable suture
Aim of specific PMCF activity
This implantable surgical suture was a non-novel legacy device, originally certified under the MDD and on the market for over 10 years. The manufacturer presented the notified body with sufficient clinical data derived from clinical studies, clinical literature, and PMS activities to support the safety and performance outcomes for the functional lifetime of the device. However, limited data were available to support shorter-term (<12 months) device-specific outcomes as opposed to earlier procedure-related or healing-related outcomes. The aim of the PMCF activity was to collect device-specific clinical data across its various surgical applications to support shorter-term safety and performance of the device in support of MDR CE marking.
 
Objectives
  • Confirm the short-term safety and performance of the subject device for all indications across the target population.
  • Confirm continued alignment with the state of the art regarding device performance.
  • Identify previously unknown side effects and monitor the identified side effects and contraindications through real-world usage of the device.
  • Identify and analyze emergent risks based on factual evidence.
  • Ensure the continued acceptability of the benefit-risk ratio.
  • Identify possible systematic misuse or off-label use of the device with a view to verifying that the intended purpose is correct.
 
Methodology
A noninterventional, retrospective, patient chart review PMCF survey was conducted. In brief, more than 100 physicians who reported use of the device in the previous 12 months completed a total of more than 500 questionnaires. The questionnaires contained a series of questions designed to address the specified survey objectives for each patient chart. The sample size required per indication was determined to ensure the statistical validity of the results.
 
The information presented by the manufacturer included:
  • Rationale supporting conduct of a retrospective chart review survey rather than a prospective follow-up study or clinical investigation;
  • Statistical methods for the determination of the required sample size;
  • Inclusion/exclusion criteria for the qualification of survey respondents;
  • Actions taken to minimize selection and response bias;
  • Consideration of ethics approval and informed consent obligations;
  • Primary and secondary endpoints, acceptance criteria, and defined justifications;
  • Variant coverage and rationale for selection;
  • Data collection time period, methods for data collection, and procedures for analysis of collected data;
  • Description of the study population including demographics;
  • Criteria for early termination or extension; and
  • Arrangements for interim and final reporting.
 
Limitations
One limitation was the potential for missing or misinterpreted data in the patient charts. Additionally, it was not possible to determine the size and diameter of the sutures used from the patient charts. Limited data were available for certain patient populations due to low device usage in this group. Physician bias or concerns may have hindered the reporting of device misuse, or physicians may not have been aware of their misuse, leading to underreporting.
 
Timelines
The study was conducted over 15 months, with 3-4 months dedicated to survey preparation, which included question and answer option validation by a smaller group of physicians, survey approval, and development of an electronic version for distribution. Three to six months were allocated to study enrollment and receipt of responses. Lastly, 3-4 months were allocated to data analysis and reporting. The timing of the corresponding clinical evaluation report update was scheduled to align with the PMCF evaluation report.
 
Case study C: Retrospective PMCF study for a Class IIa software
Aim of specific PMCF activity
The manufacturer of a Class IIa medical imagery processing and analyzing software that was new to the EU market provided the notified body with sufficient clinical evidence to support the intended use of the device. However, limited clinical data were available for certain rare indications due to low volume usage of the device for these conditions. The aim of the retrospective PMCF activity was to generate additional clinical data to support the safety and performance of the device in these rare indications.
 
Objective
The objective was to confirm the safety and performance of the software in underrepresented patient populations.
 
Methodology
The required sample size per indication was determined using statistical approaches, thereby helping to ensure the validity and reliability of the results. The acceptance criteria were defined based on the current performance claims. Anonymized datasets were collected from disease-specific databases and by request from various health institutions. The anonymized images were processed and analyzed by test software, and the outcome was compared to the healthcare practitioners’ reported outcome.
 
Limitations
The study was limited by the availability of sufficient datasets from which statistically valid conclusions could be made.
 
Timelines
The study started within 12 months of initial CE marking and was completed within 18 months of placing the device on the market.
 
Case study D: MDR conformity assessment: RWD survey for Class IIb surgical instruments
Aim of specific PMCF activity
The manufacturer of a legacy Class IIb handheld surgical laparoscopic instrument system applied to the notified body for EU MDR conformity assessment. First CE marked over 15 years ago, the legacy device had a history of safe and effective use in laparoscopic surgery, and its benefit/risk profile was well understood. To demonstrate conformity with the requirements of the EU MDR, the manufacturer presented the notified body with clinical data derived from the demonstration of equivalence, clinical literature, and PMS activities. In addition, a user-level RWD survey was employed to gather additional clinical data based on real-world usage of the devices.
 
RWD survey objective
  • Confirm the safety and performance of the device.
  • Identify and analyze known and emergent risks related to laparoscopic surgical procedures or surgical instruments.
  • Identify possible systematic misuse or off-label use of the device.
 
Methodology
A questionnaire was issued to a statistically valid sample of surgeons from a representative sample of health institutions across the EU. The questions were designed to gather performance, safety, and usability data from a well-represented variety of laparoscopic surgical procedures covering the full range of indications for use. As the device is a general surgical tool normally not mentioned in research articles, its safety and performance were measured by procedural success rather than by patient-related outcomes.
 
Limitations
The collected data were representative of the whole instrument system. Therefore, a follow-up PMCF activity was required to gather data on the individual device variants.
 
Timelines
The study was completed in less than 12 months, and the data were included in the submission for EU MDR CE marking. The protocol and timelines for the follow-up activity were also submitted to the notified body in support of demonstrating conformity with the PMCF requirements per Annex XIV Part B.
 
Conclusion
While the US and EU both have a general requirement to collect clinical data in the postmarket setting, they differ in their acceptance of RWD and RWE to confirm long-term safety and efficacy (performance) of medical devices. In the US, the FDA directly supports the use of RWE, such as through the funding of the NEST project. Under the EU MDR, the manufacturer decides if and what type of RWE they will include in their PMCF activities. The article presented examples of RWD that were accepted as PMCF data from a notified body. Still, not all notified bodies may consider the same RWD as sufficient clinical data.
 
In the future, it would be desirable to have a more globally harmonized definition of RWD and RWE, and to have the same RWD sources accepted by regulatory bodies in multiple regions. This would ensure the high safety standards of medical devices in the US and the EU are maintained while lowering the financial burden on device manufacturers to place new devices or keep existing devices on the market. RWE is not the cure-all for all clinical data gap problems, but it is an excellent tool for PMCF activities to collect postmarket clinical data on real-world medical device usage.
 
Abbreviations
BSI, British Standards Institution; EMR, electronic medical record; EU MDR, Medical Device Regulation; FDA, Food and Drug Administration; FD&C Act, Federal Food, Drug, and Cosmetic Act; HIPAA, Health Insurance Portability and Accountability Act; IDERHA, Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance; MDCG, Medical Device Coordination Group; MDD, Medical Device Directive; PMCF, postmarket clinical follow-up; RWD, real-world data; RWE, real-world evidence.
 
About the authors
Matthias Fink, MD, has been a board-certified orthopedic surgeon and senior clinical consultant with Akra Team Inc. since 2023. Dr. Fink consults medical device manufacturers, from startups to global manufacturers, on regulatory and clinical requirements with a focus on the EU MDR. Before that, he worked for seven years as a clinical reviewer and team leader at TÜV SÜD in Germany and the US. He can be reached at [email protected]
 
Amelia Hufford, PhD, is the senior vice-president of clinical and regulatory science and co-founder of 3Aware, a clinical data solution serving the real-world data needs of healthcare and medical device manufacturers. Dr. Hufford has 20 years of experience in scientific and clinical research, including 10 years within the medtech industry. She has led teams in regulatory and clinical affairs and has guided the approval and continued market access of many medical products. Using information buried within existing electronic medical records, she and 3Aware have pioneered methods of uncovering key elements of patient outcomes following treatment. She can be reached at [email protected]
 
Scott Snyder, PhD, has spent over 20 years with Cook Medical, where he is currently senior director of statistics and data science. Dr. Snyder has helped advance many products through the FDA, PMDA, NMPA, and the EU by developing and defending statistical strategy, supporting and leading regulatory audits of clinical data, and advancing real-world data initiatives. Dr. Snyder is a member of the American Statistical Association and the Society of Clinical Trials and has participated in the NESTcc Research Methods Sub-Committee to guide the development of real-world evidence. He can be reached at [email protected]
 
Breda Kearney, MSc, is a clinical regulatory lead with the British Standards Institution (BSI). Kearney has over 15 years of experience in quality management systems and regulatory compliance. In recent years, she completed her master’s in medical technology regulatory affairs. Her thesis specialized in clinical evaluation and real-world evidence, leading to the publication of several peer-reviewed articles. She can be reached at [email protected]
 
Susan Partridge, PhD, is a clinical regulatory lead at BSI with over 15 years of experience in the orthopedic medical device industry. She has performed clinical evaluation assessments as part of the orthopedic and dental team at BSI and written clinical evaluation reports for various classes of orthopedic devices in industry. She has a PhD in medical engineering and an academic research background. She can be reached at [email protected]
 
Citation Fink M, et al. From data to decisions: Real-world evidence for medical devices in the US and the EU. Regulatory Focus. Published online 9 July 2025. https://www.raps.org/News-and-Articles/News-Articles/2025/7/From-data-to-decisions-Real-world-evidence-for-med
 
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