Performing Clinical Evaluations: Article 61(10) Under the MDR

Under Article 61(10) of the MDR, it is up to the manufacturer to specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant General Safety and Performance Requirements (GSPRs) and that this evidence be appropriate given the device’s characteristics and intended purpose. For certain devices, particularly accessories to medical devices, manufacturers may determine that performing clinical evaluation following an approach aligned with Article 61(10) of the MDR is appropriate. However, manufacturers should take care with this approach to ensure that, where applicable, clinical evaluation reports prepared under this approach meet Notified Body expectations for such reports while maintaining conformity with MDR requirements in alignment with current guidance. In this article, we cover several relevant considerations for manufacturers applying an Article 61(10) approach for clinical evaluation. 

Approaching clinical evaluations with Article 61(10) of the MDR

The approach to clinical evaluation established under Article 61(10) within the MDR is based on: 

• • Demonstration of GSPR conformity as sourced from clinical data not being deemed appropriate, and
  • Justification being given based on: 
    • • Results of the manufacturer’s risk management 
        • • Consideration of the specifics of the interaction between the device and the human body 
          • Intended clinical performance 
          • Manufacturer’s claims
  • The justification is in the technical documentation and includes why the manufacturer considers the demonstration of GSPR conformity based on non-clinical testing methods alone (including performance evaluation, bench testing, and pre-clinical evaluation), to be adequate.

As the clinical evaluation plan specifies and justifies the level of clinical evidence necessary to demonstrate conformity with the relevant GSPR, per Article 61(1), it is the most appropriate location in which to address each of the items above when applying an Article 61(10) approach as it is also an element of the technical documentation. 

MedEnvoy provides manufacturers assistance in performing clinical evaluations. Request a proposal.

Using the Article 61(10) approach under the MDR

Taking a proprietary battery that is intended exclusively for use as a backup power source in hospital multiparametric patient monitors as an example, and applying the elements of justifying an Article 61(10) approach, we may be able to note: 

The scenario above is just one example of how an Article 61(10) under the MDR approach could be justified in a clinical evaluation plan, however, it is also important to ensure that the plan and clinical evaluation report also meet Notified Body expectations. 

Notified Body expectations

Guidance in MDCG 2020-13 establishes a clinical evaluation assessment report template for Notified Bodies. Section J establishes special considerations for Notified Bodies during the assessments of clinical evaluations prepared under an Article 61(10) approach and serves as guidance for manufacturers preparing such reports to ensure that these considerations are addressed. 

One common misconception by manufacturers applying an Article 61(10) under the MDR, is that a literature search is unnecessary. This can largely be attributed to “reports published in the peer-reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated” being among the types of ‘clinical data’ listed under Article 2(48). However, MDCG 2020-13 makes it clear that literature searches are an expected source of data to be considered under an Article 61(10) approach. Specifically, this guidance indicates that literature searches performed under such an approach should address: 

• • •  Search and identification of any available clinical data for the device or an equivalent device (which includes an evaluation of any such clinical data, and appraisal of their relevance to the device under evaluation) 
    • Search and identification of any available clinical data for similar devices (which should be included in the CER and may be of relevance to PMS and PMCF planning) 

Therefore, even in the absence of equivalency claims in the clinical evaluation, the literature search should utilize search terms and queries for the subject device and similar devices. This would encompass both safety and performance (subject device) and state-of-the-art (similar devices) searches. 

Additionally, while “clinical relevant information coming from post-market surveillance, in particular, the post-market clinical follow-up” is also listed under Article 2(48) as another example of ‘clinical data’, information from PMS/PMCF should be included in an Article 61(10) clinical evaluation report. Such information either further substantiates the justification given for the Article 61(10) approach (particularly regarding risk management results) or may indicate that an Article 61(10) approach is inappropriate. This would include publicly available information in vigilance databases on the subject, equivalent and/or similar devices, as applicable. 

Learn more about Article 61(10) of the MDR with MedEnvoy

This article briefly touches on some of the considerations for manufacturers when taking an Article 61(10) of the MDR approach to clinical evaluation. Contact MedEnvoy today to ensure your device meets clinical evaluation performance standards under the MDR. MedEnvoy also provides consulting services, learn more about our subject matter experts by clicking here.

Related articles:

• • MDR Clinical Evaluation Reports for Lower-Risk Class Devices
  • Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers