Real-world evidence is becoming an increasingly important part of medical device clinical evidence strategy. For manufacturers navigating both U.S. and European regulatory expectations, the question is no longer whether real-world data can be useful. The more important question is whether the data are relevant, reliable, fit for purpose, and capable of supporting defensible regulatory decisions.

A recent RAPS Article of the Year Award-winning paper, From Data to Decisions: Real-World Evidence for Medical Devices in the U.S. and the EU, co-authored by Matthias Fink (AKRA Team), Amelia Hufford (3Aware) , Scott Snyder (Cook Medical), Breda Kearney (BSI), and Susan Partridge (BSI), explores how RWE is being accepted and evaluated in both regions. The article compares U.S. and EU regulatory approaches, provides industry and notified body perspectives, and includes four anonymized case studies where RWE collected through post-market clinical follow-up activities was accepted by a notified body in support of CE marking.

The U.S. and EU share the same goal, but not the same regulatory structure

In the U.S., FDA oversight is centralized and has historically emphasized premarket review, especially for higher-risk devices. Although postmarket surveillance plays an important role, the U.S. regulatory model places significant weight on demonstrating safety and effectiveness before a device reaches the market.

The EU system is structured differently. It relies on notified bodies and has historically placed greater emphasis on conformity assessment and post-market responsibilities. With the implementation of the EU Medical Device Regulation, the EU has moved toward more rigorous clinical evidence expectations, stronger postmarket surveillance, and continuous post-market clinical follow-up.

This distinction matters because it shapes how real-world data and real-world evidence are evaluated. Both regions recognize the value of real-world clinical data, but the mechanisms, expectations, and decision pathways are not identical.

RWE is valuable, but only when the data can answer the question

RWE is not automatically useful simply because it comes from real-world care. The value of RWE depends on whether the underlying RWD can answer a specific clinical or regulatory question.

RWD may come from electronic health records, registries, claims databases, wearable devices, mobile health applications, and other sources generated outside traditional clinical trials. These sources can provide insight into how devices perform across broader and more diverse patient populations, including longer-term outcomes and real-world patterns of use.

However, data quality, relevance, methodology, and bias control are essential. For FDA, RWE must be grounded in data sources and methods that are appropriate for the question being studied. Rigorous study design remains critical, even when the data source is retrospective or observational.

For 3Aware, this is one of the most important takeaways: RWE should not be positioned as a shortcut around clinical evidence. It should be positioned as a way to generate stronger, more contextual, and more scalable evidence when the underlying data are fit for purpose.

In the U.S., RWE is increasingly part of total product lifecycle oversight

RWE can support FDA decision-making across the medical device lifecycle.

FDA has long recognized that some device risks and benefits may only become clear once a device is used in routine clinical practice. As a result, FDA may rely on post-market mechanisms such as advisory committees, post-approval studies, and Section 522 post-market surveillance orders to evaluate emerging questions or safety concerns.

FDA also more broadly supports RWE infrastructure, including guidance on the use of RWE for medical device regulatory decision-making and support for NEST through the Medical Device Innovation Consortium. These efforts reflect FDA’s interest in using RWE when the data are relevant and reliable enough to support regulatory questions.

The practical implication for manufacturers is clear: RWE can play a role beyond traditional post-market obligations. It can help inform safety questions, long-term performance, labeling considerations, post-approval commitments, and broader lifecycle evidence strategies.

In the EU, RWE is closely tied to PMCF and ongoing clinical evaluation

Under EU MDR, PMCF is a continuous responsibility. Manufacturers must proactively collect and evaluate clinical data after a device is placed on the market. PMCF supports confirmation of safety and performance, monitoring of side effects and contraindications, identification of emerging risks, reassessment of benefit-risk, and detection of possible misuse or off-label use.

Although the EU MDR does not treat RWE as a universal solution, it allows manufacturers to use multiple scientifically valid clinical data sources. The article notes that RWE can be a strong contributor to PMCF when the underlying data are relevant and reliable.

The article also points to an important gap: Europe currently lacks medical-device-specific RWD quality guidance comparable to FDA’s RWE guidance. However, broader regulatory initiatives and public-private collaborations are beginning to address this need.

For manufacturers, this means EU RWE strategies must be carefully justified. The data source, population, endpoints, methodology, limitations, and transferability to the intended use population all matter.

Device-specific RWE requires more than general healthcare data

What do manufacturers actually need from RWD partners? Many organizations claim to provide medical device RWD, but few can meet the full needs of device manufacturers. To support safety and performance questions, data partners must be able to link specific device model numbers to specific patients, provide access to unstructured procedural and outcome information, track patients longitudinally, and extract key EMR elements relevant to device safety and performance. This is where medical device RWE differs from more general healthcare analytics.

Notified bodies evaluate RWE case by case

The notified body perspective is especially useful for EU-facing manufacturers. Notified bodies may accept RWD as part of a PMCF strategy or broader clinical evidence package, but acceptance depends on the device, the risk class, the research question, the methodology, the study population, sample size, endpoints, acceptance criteria, data quality, and the totality of evidence available.

Manufacturers must also critically evaluate both favorable and unfavorable findings. Results need to be interpreted in the context of the device’s intended purpose, patient population, state of the art, risk management, and benefit-risk profile.

This reinforces the importance of designing RWE studies prospectively, even when using retrospective data. The strongest RWE programs begin with a clear question, predefined objectives, transparent methods, and an honest assessment of limitations.

Four case studies show how RWD can support PMCF

The following four anonymized examples illustrate where RWD was accepted by a notified body in support of EU MDR evidence needs.

The first case involved a Class III total knee replacement. The manufacturer had clinical literature, PMS data, and clinical studies, but needed longer-term evidence across the device lifetime. A device-specific registry was used to collect real-world clinical data, including outcomes and adverse events. The study required careful justification of participating sites, registry design, data quality, and reporting strategy.

The second case involved a Class III implantable surgical suture. The manufacturer used a retrospective chart review survey to gather device-specific clinical data across surgical applications. The submission included statistical justification, respondent criteria, bias mitigation, endpoints, acceptance criteria, and reporting plans.

The third case involved Class IIa medical imaging software. The manufacturer used anonymized datasets from disease-specific databases and health institutions to generate additional evidence in rare indications where clinical data were limited. This example illustrates how RWD can help address underrepresented patient populations or low-volume use cases.

The fourth case involved Class IIb laparoscopic surgical instruments. The manufacturer used a survey-based RWD approach to gather safety, performance, and usability data across real-world surgical procedures. Because the device was a general surgical tool, outcomes were tied to procedural success rather than direct patient-level endpoints.

Together, these examples show that RWE can support PMCF in different forms, including registries, chart reviews, datasets, and surveys. But in every case, acceptance depended on the quality of the method, the relevance of the data, and the ability to connect the evidence back to specific clinical objectives.

RWE is not a cure-all, but it is becoming essential

RWE will not solve every clinical evidence gap, and not every RWD source will be acceptable for every regulatory purpose. However, RWE can be a powerful tool for PMCF and postmarket clinical data generation when designed and executed appropriately.

For MedTech manufacturers, the implication is clear: RWE should be treated as a strategic evidence capability, not a reactive compliance exercise. As regulatory expectations continue to evolve in both the U.S. and EU, companies that can generate fit-for-purpose, traceable, clinically contextualized RWE will be better positioned to support ongoing market access, lifecycle management, and device innovation.

At 3Aware, this is exactly the challenge we are focused on solving: transforming longitudinal clinical records, including structured and unstructured data, into defensible real-world evidence that helps manufacturers understand how devices perform in actual care settings.

View the RAPS article here (membership paywall).