Article 61(10) of the Medical Device Regulation (MDR) 2017/745 plays a pivotal role in ensuring the safety and performance of specific types of medical devices for which demonstrating conformity based on clinical data is not deemed appropriate. The key aspects of clinical evaluation under this article and its importance in the lifecycle of medical devices is further detailed in this article.
What is a clinical evaluation without clinical data?
In the context of medical devices, clinical evaluation is a systematic process used to assess the safety and performance of a device based on clinical data. Typically, clinical data includes information gathered from clinical trials, studies, or other real-world evidence. However, in some cases, clinical evaluation without clinical data may be necessary and/or possible.
This concept may seem counterintuitive, as clinical data is generally considered a cornerstone of evaluating a device’s safety and effectiveness. However, the Medical Device Regulation (MDR) 2017/745 allows for some flexibility and refer to Article 61 (10):
“Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre- clinical evaluation, to be adequate.”
This is where Article 61(10) of the MDR 2017/745 can be applied.
Which MDCG Guidances are relevant for 61(10)
Up to this date no specific Guidances were published by Medical Device Coordination Group (MDCG) in which the approach of the clinical evaluation without clinical data is described.
Nevertheless Article 61(10) is tangential mentioned in the three MDCG guidances as follows:
The purpose of this guidance is to provide a framework for the determination of the appropriate level of CLINICAL EVIDENCE required for MEDICAL DEVICE SOFTWARE (MDSW) to fulfil the requirements set out in Regulation (EU) 2017/745 – Medical Devices Regulation (MDR) and Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Devices Regulation (IVDR):
For medical devices, where the demonstration of conformity with GSPRs based on clinical data is not deemed appropriate (MDR Article 61 (10)), the manufacturer shall duly substantiate in the technical documentation why it is adequate to demonstrate conformity based on the results of non-clinical testing methods alone, including PERFORMANCE EVALUATION, bench testing and preclinical evaluation, and USABILITY assessment.
A guidance directed to manufacturers and notified bodies. This guidance supports a harmonised approach with respect to clinical data providing sufficient clinical evidence necessary to demonstrate conformity with the relevant General Safety and Performance Requirements (GSPR) across European Union Member States:
The manufacturer should conduct an analysis with respect to the GSPRs of the MDR, to determine if additional data to support the clinical evidence are required to meet additional MDR requirements. This could be achieved either through a gap analysis with respect to new MDR requirements, or by creation of an entirely new analysis for the MDR. As noted in Section 3, Article 61(10) cannot be applied to Class III or implantable devices, but may be applied to some or all requirements for confirmation of conformity with relevant GSPRs for all other device classifications if adequately justified.
Where other evidence, for example results of pre-clinical testing etc. as described in MDR Article 61(10), is used for confirmation of safety and performance, PMCF studies may be undertaken to confirm these conclusions.
A template directed to manufacturers and notified bodies for drafting their clinical evaluation report as per MDR. The template features a specific section on CERs as per Article 61(10):
Section J: Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))
What must be considered from a regulatory perspective?
It is crucial to carefully consider the application of Article 61(10). The notified body also follows this process, as outlined in MDCG document 2020-13 (Clinical Evaluation Assessment Report). Notified bodies assess whether:
- There is adequate justification for the application.
- The available clinical evidence is sufficient.
- Clinical literature on the product or an equivalent product has been thoroughly searched (if available).
- The results from risk management support the application of Article 61(10).
- There is enough information regarding the interaction between the product and the human body (contact with materials).
- The intended performance of the product can be demonstrated based on non-clinical data.
- Any marketing claims are substantiated by clinical data.
Under such circumstances, according to MDR Article 61 section 10, the safety and performance of such medical devices can be demonstrated with the non-clinical testing methods alone, including:
- results of risk management,
- performance evaluation,
- technical tests,
- bench tests,
- usability tests,
- simulated use / animal / cadaveric testing,
- clinical experience derived from internal vigilance data and external databank can be also included.
It is essential that an adequate assessment of the product’s benefit-risk ratio can be made based on the available data.
Which products/product types are covered by this article – and which are probably not?
As mentioned and regulated by the Medical Device Regulation 2017/745 (MDR) the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed necessary for specific types of medical products.
Examples of medical devices for which the application of Article 61(10) could be justified are:
- mouth spatula
- HF-cable (high frequency)
- foot-switches
- patient positioning systems
- operating lights
- stand-alone software (see MDCG 2020-1)
- wheelchairs
- walking aids
- (some) medical devices with measuring function
Note: 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 half-sentence „Without prejudice to paragraph 4“and is also clearly stated in MDCG document 2020-6:
“Article 61(10) cannot be applied to Class III or implantable devices. In exceptional cases Article 61(10) may be applied for all other device classifications.”
In addition the focus for clinical evaluation of medical devices as per Article 61(10) is partially shifted to PMCF data as lined out in MDCG document 2020-6:
Where other evidence, for example results of pre-clinical testing etc. as described in MDR Article 61(10), is used for confirmation of safety and performance, PMCF studies may be undertaken to confirm these conclusions.
In conclusion it can be said that Article 61(10) of the MDR reinforces the importance of clinical evaluation in the lifecycle of any medical device. Manufacturers must invest in robust clinical evaluation processes including pre-market evaluation, market approval, and post-market stages incl PMCF. Ensuring continuous and comprehensive clinical data collection– be it pre- or post-market – is key to meeting regulatory requirements and safeguarding patient health. seleon can support you in generating this kind of data as required for your medical device.
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.
