Clinical evaluation without clinical data

Article 61(10) of the MDR regulates the possibility of conducting a clinical evaluation without clinical data. The cases in which this is possible and the conditions under which this article can be applied are explained below.

According to Article 61(10) of the Medical Device Regulation (MDR), a clinical evaluation may be conducted without clinical data in certain cases. However, it is important to note that a clinical evaluation is still required even when this article is applied.

When is it possible to apply Article 61(10)?

When applying Article 61(10), the use of clinical data to demonstrate conformity with the essential safety and performance requirements may be waived if it is deemed inappropriate. In such cases, the manufacturer must provide adequate justification based on:

• the results of risk management and
• the specific interactions between the product and the human body,
• the intended clinical performance, and
• the manufacturer's specifications.

However, it should be noted that Article 61(10) cannot be applied to Class III devices or implantable devices. This restriction is expressed in the MDR by the phrase “without prejudice to paragraph 4” and is also clearly stated in MDCG document 2020-6.

For all other product classes, i.e., classes I to IIb (excluding implants), Article 61(10) may be applied. However, this should be considered an exception.

The manufacturer must adequately justify the decision to apply Article 61(10) in the clinical evaluation. This justification should be based on an assessment of the available evidence in accordance with the requirements of the MDR.

It is important to note that the application of Article 61(10) requires careful consideration. This is also what the notified body does: In accordance with MDCG document 2020-13 (Clinical Evaluation Assessment Report), notified bodies assess whether

• there is sufficient justification,
• the available evidence, e.g., in the form of performance evaluations, bench tests, and preclinical studies, is sufficient,
• clinical literature data on the product or an equivalent product has been searched for,
• a search and evaluation of clinical literature data on similar products has been carried out,
• the results of risk management support the application of Article 61(10),
• there is sufficient information on the interaction between the product and the human body,
• the intended performance of the product allows it to be based on non-clinical data,
• there are marketing claims that must be substantiated by clinical data.

Examples of medical devices for which the application of Article 61(10) could be justified are

• Mouth specula
• Dental treatment units
• Patient positioning systems
• Surgical lights
• Standalone software
• Blood glucose meters
• Wheelchairs  
• Walking aids

These products have in common that their use involves only minimal risks, which are often related to their usability. Contact with the human body, if any, is not critical. The clinical benefit is often indirect, such as supporting diagnosis or treatment.

Accordingly, the parameters used to determine the safety and performance of the products are more technical in nature. Parameters such as reproducibility of measurement or dimensional stability (for many medical devices) are easier to test in a laboratory setting than in clinical use.

Article 61(10) does not apply to all 'simpler' medical devices. As soon as there is a direct clinical benefit, for example, the performance must generally be demonstrated on the basis of clinical data—as is the case, for example, with UV lamps for the treatment of skin diseases or compression stockings for improving blood circulation.

How can safety and performance be demonstrated?

If Article 61(10) of the MDR applies, appropriate data for demonstrating safety and performance can be obtained, for example, in the following ways:

• Technical tests
• Preclinical tests
• Usability tests
• Simulations

What does this mean for clinical evaluation?

Even when applying Article 61(10) of the MDR, clinical evaluation remains essential. It is an important part of the conformity assessment procedure under the MDR. It involves assessing the safety and performance of a medical device when used for its intended purpose. If the product does not claim any clinical benefit that needs to be substantiated by clinical data, the clinical evaluation may be based predominantly on preclinical data.

It is important that the available data allows for an appropriate assessment of the product's risk-benefit ratio.

Conclusion

According to Article 61(10) of the MDR, a clinical evaluation may be conducted without clinical data if the manufacturer provides adequate justification based on the results of risk management, the specific interactions between the medical device and the human body, the intended clinical performance, and the information provided by the manufacturer. However, it should be noted that despite the application of Article 61(10), a clinical evaluation remains indispensable. Safety and performance must be demonstrated by other appropriate means, for example through technical testing.