Purpose. This article summarizes how Notified Bodies assess whether a manufacturer may rely on non-clinical data to demonstrate device safety and performance under EU MDR Article 61(10). It is intended to help manufacturers judge whether Article 61(10) is applicable and prepare a strong, robust justification.
Introduction: Article 61(10) is an exception, not a shortcut
MDR Article 61(1) sets the general principle: conformity with the relevant General Safety and Performance Requirements (GSPRs), including evaluation of undesirable side-effects and the acceptability of the benefit-risk ratio under normal conditions of the intended use, must be based on clinical data providing sufficient clinical evidence.
This means that the intended purpose defines the clinical context for assessing conformity, clinical safety, and benefit-risk acceptability. Evaluation of side-effects and benefit-risk parameters is inherently linked to that intended purpose.
Article 61(10) is an exceptional route. It changes the type of data used, but it does not change the objective of clinical evaluation.
The basic logic of Article 61(10)
In the specific circumstances covered by Article 61(10), if the manufacturer can demonstrate that clinical data are not appropriate for verifying predefined safety, performance, and benefit-risk criteria, the same evaluation objectives may be achieved through sufficiently robust non-clinical evidence.
The manufacturer must first define the intended purpose in accordance with MDR Article 2(12), Annex II Section 1.1 and Section 23.4. For software, IMDRF/SaMD WG/N81 FINAL:2025 may also be relevant. Based on the intended purpose and the applicable GSPRs, the manufacturer should identify indications, contraindications, target patient groups, intended users, relevant side-effects and other clinically relevant risks, expected clinical benefits and related outcome parameters, and current State of the Art parameters and acceptance criteria for judging benefit-risk acceptability.
For every identified parameter, the manufacturer must define the corresponding measurement method—clinical or non-clinical—and explain which method is appropriate according to the current State of the Art.
The decisive regulatory question is whether measurement and demonstration of these parameters substantively depends on clinical data, meaning safety or performance information generated from use of the device, or an equivalent device, in its intended clinical setting.
How applicability is judged
If verification of the parameters substantively depends on clinical data, the clinical evaluation is considered to be based on clinical data and Article 61(1) applies.
If the parameters can be sufficiently assessed by validated non-clinical methods, and the overall benefit-risk conclusion does not depend on clinical data within the meaning of MDR Article 2(48), the manufacturer may justify the use of Article 61(10).
In that case, non-clinical data may come from simulated-use, animal, cadaver, or phantom testing involving healthcare professionals or other end users; pre-clinical and bench testing or standards conformity; in vitro, ex vivo, computational modelling, simulation, performance evaluation, and other pre-clinical evaluations.
Limited or incidental clinical data do not automatically exclude Article 61(10). The key question remains whether it is appropriate to demonstrate conformity by relying only on non-clinical data. For Article 61(10) devices, clinical data are not the primary basis for initial conformity, but they may become important later for confirming continued safety and performance and for reassessing whether the original Article 61(10) justification remains valid.
Which devices may qualify?
As with the WET devices listed under Article 61(6)(b), it is not possible to create a fixed list of devices that qualify for Article 61(10). Even apparently simple non-implantable Class IIa or IIb devices may serve broad and diverse clinical use scenarios and may or may not carry explicit clinical claims.
Therefore, the device itself or a generic device group cannot determine applicability on its own. Applicability depends on multiple dimensions of the intended purpose and the specific clinical evaluation. Notified Bodies must assess the manufacturer’s justification case by case.
Manufacturer justification: what must be explained
For Class I, IIa, and IIb non-implantable devices, if a manufacturer wishes to use Article 61(10) to support an exemption from reliance on clinical data, the justification must consider risk management outputs, intended clinical performance, claims, and the specific characteristics of device-human interaction.
The justification should be detailed enough that a reviewer who did not participate in the clinical evaluation can understand why the manufacturer believes clinical data are not appropriate for demonstrating safety and performance for that specific device.
“There are no clinical data” or “clinical data are difficult to generate” are not valid reasons.
In every Article 61(10) justification, defining the current State of the Art is decisive. It determines which safety and performance parameters are relevant to the intended purpose and whether those parameters are normally verified through human clinical outcomes or can be sufficiently assessed by non-clinical methods.
Manufacturers should be cautious if they attempt to define safety and performance parameters only at the generic device group level. Although MDCG 2020-6 links “well-established technology” to generic device groups, the clinical application scope of lower-risk devices can be broad. In the Article 61(10) context, safety and performance parameters are often better defined at device level.
If the State of the Art shows that the safety or performance information required to achieve the intended clinical objective—such as treating a disease, reducing symptoms or complications, or improving diagnostic accuracy—is generated through clinical use of the device or an equivalent device in the intended clinical setting, conformity must rely on clinical data and Article 61(1) applies.
Article 61(10) may be possible only when, for the specific intended purpose, all key safety and performance parameters can be reliably confirmed through validated non-clinical methods, and establishing an acceptable benefit-risk profile under current medical practice does not depend on clinical data.
What Notified Bodies focus on: intended clinical performance and claims
Notified Bodies want to understand how the device functions in the clinical environment, whether its performance is critical to the success of a diagnostic or therapeutic intervention, and how it produces or facilitates improvement in patient health.
- Clearly describe the role of the device in the clinical setting. In general, the less central the device is to diagnostic or therapeutic success, the more likely Article 61(10) may apply.
- Explain how the device achieves its intended purpose. The less patient-specific characteristics affect success, the more likely Article 61(10) may apply.
- Explain how the device positively affects individual health, patient management, or public health, and how that impact is demonstrated. The greater the potential effect on health outcomes, the less likely Article 61(10) will apply.
- Clarify what actions are triggered by information generated by the device and how quickly action is taken. If the device does not trigger immediate treatment decisions or actions, Article 61(10) may be more plausible.
- Explain how superiority or alignment with the current State of the Art is demonstrated. If State of the Art safety and performance endpoints are themselves defined by clinical data, Article 61(10) is less likely to be accepted.
- Identify explicit clinical claims, such as “the device reduces pain,” and implicit clinical claims that can only be confirmed by clinical data. If such claims exist, Article 61(10) does not apply.
- Assess whether non-clinical performance testing can represent all relevant disease states, use scenarios, tissue types, patient groups, users, and other conditions the device may encounter.
The purpose of this part of the justification is to make the review team understand the clinical benefit arising from the intended purpose, the predefined parameters used to evaluate that benefit, and the measurement methods needed to verify those parameters. A manufacturer cannot state that the device has no clinical benefit, because clinical evaluation must still conclude that the benefits outweigh residual risks.
What Notified Bodies focus on: device-human interaction
Notified Bodies expect the manufacturer to describe how the device interacts with the human body, including the nature and extent of contact. Interaction is not limited to physical contact. For example, an AI device may interact with cognitive processes.
- How invasive is the device? Greater invasiveness makes Article 61(10) less likely.
- Which tissue or anatomical site does the device contact? The more sensitive or critical the tissue, the less likely Article 61(10) is applicable.
- Does the device contact damaged skin, intact skin, or mucosa? No contact or contact only with intact skin makes Article 61(10) more plausible; long-term contact with damaged skin or mucosa, or invasive use, usually conflicts with Article 61(10).
- How long does the interaction last? Shorter duration supports applicability.
- Is the anatomical region the central nervous system, heart, or circulatory system? Devices intended specifically for direct contact with these areas are excluded by MDR Annex VIII classification rules.
- What is the worst-case clinical risk at the anatomical site? The less clinically relevant the risk, the more plausible Article 61(10) becomes.
- If contact occurs, can non-clinical test results be extrapolated to demonstrate absence of negative patient impact?
- Does the interaction directly alter physiological processes or tissue function? If so, applicability decreases.
- Does safety or performance depend on a biological response that cannot be fully predicted or characterized by non-clinical methods?
- Does the interaction introduce patient variability?
- Is the device a core part of a system or a standalone device? The more central it is within the system, the less likely Article 61(10) is applicable.
- Is there enough information about device-human interaction from sources other than non-clinical data?
What Notified Bodies focus on: risk management
Notified Bodies also expect to understand the risks to patient safety and/or users arising from device use, and whether those risks are sufficiently understood and accepted by the medical community.
- Based on the State of the Art, what are the device-related hazards and worst-case residual clinical risks? The more clinically relevant the risks, the less likely Article 61(10) is applicable.
- Can non-clinical safety testing represent all relevant disease states, tissue types, patient groups, users, and use conditions?
- After residual risks have been reduced as far as possible, are clinical data still needed to judge whether those risks are acceptable in view of the benefits? If yes, Article 61(10) usually does not apply.
This part of the justification should explain how non-clinical test results clearly demonstrate that clinical risk-control measures are effective when the device is used as intended, and that additional clinical testing in actual patient use would not provide valuable safety information.
Clinical evaluation documentation for Article 61(10)
The MDR does not create a separate, lighter documentation standard for Article 61(10) devices. These devices still require a complete clinical evaluation documentation package, including post-market surveillance documentation.
The main exception is that specific PMCF is usually not expected for Article 61(10) devices, and this should be stated in the PMS plan prepared under MDR Annex III Section 1.1(b). General PMCF activities as defined in MDR Annex XIV Section 6.2(b), such as literature searches and user feedback, are still normally required.
Common deficiencies identified by Notified Bodies
1. Deficiencies in State of the Art analysis
- The CER does not include a State of the Art analysis.
- The State of the Art analysis does not clearly define which meaningful safety and performance parameters should be measured according to evidence-based medicine.
- The manufacturer does not consider currently available clinical data for similar devices.
- Clinical risks are not adequately defined based on the State of the Art.
The State of the Art analysis is essential for determining which safety and performance parameters require support from non-clinical data and for supporting the manufacturer’s argument that clinical data are not appropriate. It must be comprehensive and must identify parameters for comparing the device under evaluation with similar devices.
When defining the State of the Art, manufacturers should consider the device’s role in the clinical procedure or intervention, how critical it is to success, and the potential clinical impact if it does not work as intended—such as intraoperative complications, prolonged procedure time, implantation failure, or accessory misplacement or misuse. If similar devices or generic device groups already have clinical data, demonstrating applicability of Article 61(10) may become very difficult.
2. Deficiencies in the manufacturer’s justification
- The justification merely repeats the text of MDR Article 61(10) without explaining the listed criteria or why clinical data are not appropriate.
- The manufacturer uses Article 61(10) because clinical data are absent or insufficient.
- The manufacturer treats “clinical benefit limited to patient management or public health” as a reason why clinical data are not appropriate.
- The argument relies on usability data to support safety and performance instead of clinically meaningful endpoints.
- For accessories or surgical instruments, the manufacturer claims that the device has no clinically relevant purpose and therefore does not require clinical data. This may conflict with the MDR definitions of a medical device or accessory and may call the product’s regulatory status and clinical relevance into question.
The justification should clearly and concisely explain to the Notified Body why the relevant safety and performance parameters can be sufficiently evaluated using non-clinical methods only. Because clinical data are one of the core principles for demonstrating safety and performance under the MDR, Article 61(10) justifications will receive stricter scrutiny and must address the criteria directly.
3. Deficiencies in clinical evaluation
- The manufacturer claims Article 61(10) but then relies on a body of clinical data in the clinical evaluation. Once conformity depends on clinical data, Article 61(10) no longer applies.
- The CER does not discuss relevant non-clinical testing or explain how it supports conformity at least with Annex I, GSPR 1 and GSPR 8.
- The manufacturer states that the device has no clinical benefit and therefore cannot conduct a benefit-risk analysis.
- The manufacturer does not consider implicit claims.
- During certification, the manufacturer does not revisit whether the “clinical data are not appropriate” justification remains adequate and applicable.
Some limited clinical data—such as low-quality PMS data, complaints, vigilance reports, or clinical literature involving a separate technique—may be included without adding substantive value to conformity demonstration. In such cases, Article 61(10) may still remain applicable. In other cases, such as surgical instruments specifically used with implant systems, procedure-level clinical data may indirectly but meaningfully reflect device safety and performance, making Article 61(10) unsuitable.
All medical devices and accessories should have a clinical benefit; otherwise, their scope under the MDR itself may be questioned. For accessories, the clinical benefit may be indirect, such as facilitating a therapeutic or diagnostic intervention. Explicit and implicit claims should both be evaluated.
The justification must also be revisited over time. New or unexpected clinical data for the device itself, similar devices, or equivalent devices, or changes in the State of the Art, may affect the continued acceptability of the Article 61(10) route.
4. Deficiencies in PMS and PMCF
- No PMS plan is provided and/or no general PMCF activities are planned.
- The manufacturer intends to collect clinical data through specific PMCF but does not justify why this is consistent with Article 61(10).
Under the MDR, manufacturers must monitor safety and performance after market placement according to the PMS plan in Annex III. General PMCF activities, such as literature searches and user feedback, should continue to support the position that clinical data are not appropriate. However, collecting clinical data through specific PMCF activities under Annex XIV Part B Section 6.2(b) often indicates that clinical data are in fact appropriate for demonstrating safety and performance, which usually undermines the Article 61(10) position.
Manufacturers are advised to communicate with their Notified Body in a structured way to discuss the acceptability of the proposed strategy.
Conclusion
The core message of the Team-NB position paper is clear: Article 61(10) is not a route to use simply because clinical data are unavailable. It may be used only when the State of the Art clearly supports the position that safety and performance can be fully demonstrated through robust non-clinical evidence.
What Notified Bodies really care about is not whether the manufacturer has written a paragraph claiming Article 61(10). They care whether the manufacturer can explain three things clearly: what the device does, how it interacts with the human body, and how risks are controlled to an acceptable level.
The paper repeatedly emphasizes that the State of the Art analysis is foundational. It determines which parameters must be assessed, how they should be assessed, and whether clinical data are intrinsically irreplaceable.
For manufacturers, the most practical takeaway is that the justification cannot be generic. It cannot simply repeat regulatory text, it cannot use Article 61(10) merely because clinical data are limited, and it cannot treat usability data as a substitute for clinically meaningful endpoints.
For accessories, surgical instruments, and lower-risk non-implantable devices, this position paper is especially useful. It reminds manufacturers that even a device that appears simple may not qualify if it plays a critical role in a clinical workflow, if its safety or performance requires clinical data for assessment, or if it has clinical outcome impact or direct clinical benefit.
For marketed devices, the paper also sends an important signal: Article 61(10) is not a one-time fixed decision. New clinical evidence arising through PMS and PMCF, evidence from similar devices, and changes in the State of the Art may all affect whether the original justification remains valid.
Team-NB’s latest position further clarifies the boundaries of EU MDR Article 61(10). Manufacturers may use this pathway only when clinical data are not necessary for demonstrating safety and performance, and when non-clinical evidence is sufficient to support conformity. The paper also identifies three key review dimensions—intended clinical performance, device-human interaction, and risk management—which provide highly practical guidance for EU registration and clinical evaluation.
Clinsota’s clinical and regulatory team has long-standing experience with EU MDR Article 61(10) projects, including clinical evaluation, technical justification, and Notified Body communication for multiple categories of non-implantable devices. For companies assessing whether a product may fit Article 61(10), building a Notified Body-acceptable non-clinical evidence system, or reducing downstream deficiency and audit risks, we welcome discussion with industry partners to translate complex regulatory logic into an executable and certifiable pathway.