Under the European Medical Device Regulation (MDR) 2017/745, the general rule is that clinical evaluation must be based on sufficient clinical evidence. However, Article 61(10) offers an exceptional pathway where, in specific cases, a manufacturer can rely on a robust body of non-clinical evidence to demonstrate safety and performance.
But how do you know if your device qualifies, and how do you convince a Notified Body? Based on the latest position paper from Team-NB, here is what you need to know.
Understanding the Exception: Article 61(10)
Article 61(10) does not change the objectives of a clinical evaluation; it only modifies the type of data used. This pathway is primarily intended for Class I, IIa, and IIb non-implantable devices. To use it, you must justify that clinical data is not appropriate for verifying the device’s safety and performance criteria.
It is important to note that Article 61(10) is not a loophole for when clinical data is simply “not available” or “difficult to generate”. Instead, the justification must show that, according to the state of the art, the device’s parameters can be adequately evaluated through validated non-clinical methods.
The Three Pillars of a Robust Justification
When a Notified Body reviews your Article 61(10) claim, they look at three critical areas to determine if the justification is acceptable:
- Intended Clinical Performance and Claims:
- If the device is not directly responsible for the clinical outcome (e.g., an accessory), the more likely Article 61(10) applies.
- Crucially, if you make explicit clinical claims (e.g., “reduces pain”), Article 61(10) is generally not applicable because those claims must be supported by clinical data.
- Device and Human Body Interaction:
- The Notified Body evaluates how invasive the device is and the duration of contact.
- If the device interacts with vital tissues (like the heart or central nervous system) or modifies physiological processes, Article 61(10) is unlikely to be accepted.
- Risk Management:
- You must demonstrate that non-clinical testing alone unequivocally proves that clinical risks are controlled.
- If clinical data is still required to determine if residual risks are acceptable, Article 61(10) will not apply.
The Role of State of the Art
Defining state of the art is the most decisive part of your justification. It determines whether safety and performance parameters are normally verified through human clinical outcomes or if bench testing and animal models are the standard.
A common pitfall is failing to define these parameters clearly or ignoring that similar devices in the market already rely on clinical data. If clinical data is available for similar devices, justifying the non-clinical route becomes very difficult.
Sources of Non-Clinical Data
If Article 61(10) is justified, manufacturers can draw from several non-clinical sources:
- Simulated use, animal, or cadaveric testing involving end users.
- Pre-clinical and bench testing, including compliance with recognized standards.
- In silico testing, in vitro, Ex-vivo, computational modeling, and performance evaluations.
Common Red Flags for Notified Bodies
Notified Bodies frequently identify deficiencies in Article 61(10) submissions. To ensure a smooth assessment, avoid these mistakes:
- Claiming “No Clinical Benefit”: Every medical device must have a clinical benefit. If you claim there is none, it raises questions about whether the product even falls under the MDR. For accessories, consider “indirect benefits” like facilitating a procedure.
- Ignoring Implicit Claims: Some claims are not directly written but are naturally linked to the device’s purpose. Notified Bodies also evaluate these implied claims during assessment.
- Mixing Pathways: Article 61(10) can only be used when conformity is demonstrated using non-clinical data alone. If clinical data is included to prove safety or performance, this pathway is generally no longer applicable.
- Specific PMCF without Rationale: Planning specific PMCF studies may indicate that clinical data is still needed. This can contradict the justification for using Article 61(10).
Post-Market Responsibilities
Even for Article 61(10) devices, Post-Market Surveillance (PMS) is mandatory. While specific clinical studies (specific PMCF) are usually not expected, general PMCF activities such as literature searches and user feedback are required to ensure the Article 61(10) justification remains valid over time.
Conclusion
The Article 61(10) pathway requires a strong technical justification supported by non-clinical evidence. The Notified Body evaluates each case individually. Manufacturers should provide a clear, evidence-based rationale demonstrating that safety and performance can be adequately established through non-clinical data, while carefully addressing device body interaction, intended clinical performance, and residual risks.
Reference
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng#art_61
