Clinical evaluation according to Article 61(10) of Medical Device Regulation (EU) 2017/745 

Purpose of conducting a clinical evaluation

Regulation (EU) 2017/745 (article 2(44)) relating to medical devices defines clinical evaluation as “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer”. Thus, the clinical evaluation consists of the analysis of the clinical data available on the medical device with the aim of demonstrating its compliance with the general safety and performance requirements (GSPR) of Annex I. Clinical evaluation for medical devices must be carried out according to precise conditions defined in Article 61 of Regulation (EU) 2017/745. It is notably specified that the clinical data evaluated must provide sufficient clinical evidence, depending on the characteristics and intended use of the device.

Article 61(10) application scope 

In certain cases, the use of clinical data may be considered inappropriate to demonstrate compliance with the GSPR: clinical evaluation of the medical device is then based on paragraph 10 of Article 61 of Regulation (EU) 2017/745. This strategy cannot apply to implantable and class III devices for which clinical data are mandatory, except for special cases. Concerning all other devices, the “61(10)”strategy can be applied when the performance and safety of the device can be demonstrated by non-clinical data and there are no relevant or significant measurable clinical criteria.

A clinical evaluation in accordance with article 61(10) must be detailed in a clinical evaluation plan and report and must provide a summary of the non-clinical data used to demonstrate compliance with the applicable safety and performance requirements. These data should enable an evaluation of the performance, benefits and safety of the device evaluated.

If a manufacturer decides to follow this clinical evaluation methodology , then appropriate justification must be provided explaining why a demonstration of compliance with the GSPR can be based solely on the results of non-clinical testing methods. This justification must be based on the following elements:

• The interaction between the device and the human body. In most cases, Article 61(10) applies to devices without direct interaction with the human body. It can also apply to certain devices having direct interaction with the human body by taking into account the duration of contact, the type of contact, mode of action and the type of tissue in contact with the device.
• The device’s intended clinical performance and the manufacturer’s claims. The performance claimed by the manufacturer must be technical in nature in order to claim Article 61(10).
• The device’s intended clinical benefit and the manufacturer’s claims. To claim Article 61(10), the device evaluated must no provide measurable direct clinical benefit. This does not mean, however, that the device has no clinical benefit. Indeed, the clinical benefit may be indirect, arising from the technical performance of the device. It will then be acceptable for it to be demonstrated by non-clinical data.
• The risks associated with the use of the device, which must be demonstrated by non-clinical tests.
• The degree of novelty of the device, which must be low.
• The relevance and/or feasibility of a clinical investigation. For certain types of devices, clinical investigations may be irrelevant, impractical, or unethical. The performance, safety and clinical benefit of the device can then be demonstrated by non-clinical trials.

However, if clinical data are not considered appropriate to demonstrate compliance with GSPR, this does not mean that these data  should be excluded from the clinical evaluation if they do exist. Therefore, a review of the literature must always be carried out in order to identify the data available on the device under evaluation.

Finally, application of clinical strategy based on Article 61(10) does not exempt a manufacturer from collecting clinical data for a device with a clinical benefit and clinical performance. A lack of available clinical data does not justify the 61(10) clinical evaluation route. This methodology should only be considered when clinical data are considered inappropriate or irrelevant for evaluating the performance, benefits and safety of the device.

Our intervention

Our clinical evaluation experts can help you to choose the appropriate clinical evaluation strategy for your device. Our team can also support you in drafting justifications for your chosen strategy or to write your clinical evaluation documents in compliance with the new Regulation (EU) 2017/745 requirements of:

• Clinical Evaluation Plan (CEP)
• Clinical Evaluation Report (CER)
• Post-Market Clinical Follow-up plan and report (PMCF plan and report)
• Summary of Safety and Clinical Performance (SSCP).

Contact us at onedt@efor-group.com