Team-NB Position on MDR Article 61(10) Part 2 Guides Use of Non-Clinical Data and CERs

By Heather Crawford and Evangeline Loh

Team-NB position paper on Article 61(10)

As Emergo experts have reported, an important element of device design and development is the well-developed intended use statement. With the GSPR, indications, contraindications, patients, users, side-effects, clinical risks, intended clinical benefits and outcome parameters, and state-of-the-art- (SOA) based parameters and acceptance criteria for determining the acceptability of the benefit-risk ratio. For defined parameters, the manufacturer needs to determine whether the corresponding measurement method is clinical, or for Article 61(10), non-clinical, according to the SOA. 

In particular, three criteria for assessment of Article 61(10) devices are discussed further in the paper: intended clinical performance and claims, interaction between the device and human body, and risk management. 

NB review: Intended clinical performance and claims

For all devices, the CER must describe how the device performs within the clinical setting, the relationship of the device performance to the overall diagnostic or therapeutic intervention and the clinical benefit (improvement in patient health). For patient clinical benefit, how is the favorable impact demonstrated? 

Article 61(10) is more likely to be applicable if the device is less correlated to the success of the clinical intervention, less likely that individual patient characteristics impact the success of the intended purpose of the device, if the device does not lead to immediate patient treatment decision or action, and if non-clinical testing is representative of all possible states in which the device is used: disease states, body contact, tissue types, patients and users. 

NB Review: Device and human body interaction

The CER for all devices needs to describe how the device interacts with the human body, including the nature of the contact, as well as the duration. This explanation would state the invasiveness of the device, the body tissue contact and anatomical location, contact with intact skin or injured skin, the length of contact with the human body, clinical risks and so forth. 

Article 61(10) is more likely to be applicable if the device is less invasive, contacts less sensitive or vital tissue, contacts only intact skin, clinical data is not required to assess the acceptability of residual risks, non-clinical testing can be extrapolated to demonstrate there is no negative impact on the patient and contributes less to the capability of a system to achieve its intended purpose.

NB review: Risk management

Again for all devices, the CER must provide information about the risks to patient safety and the user. Article 61(10) is more likely to be applicable if device-related harms and residual clinical risks are less clinically relevant, and the non-clinical safety testing supports all possible disease states, tissue types, patients, and users, and clinical data is not required to determine the acceptability of residual risks, considering the clinical benefits. 

To support Article 61(10), Team-NB recommends a summary of clinically relevant risks, an outline of how these clinical risks are mitigated through design controls and non-clinical testing. 

Additional recommendations

The position paper describes SOA analysis deficiencies. While specific to Article 61(10) devices, this is valuable for all manufacturers’ CERs to consider: include SOA analysis, define meaningful safety and performance parameters which are expected to be measured (based on published literature, evidence-based medicine), assess clinical data from similar devices, and define clinical risks based on SOA. One note related to SOA, if clinical data is available for similar devices or the generic device group, it may be more difficult to leverage Article 61(10).  

Concluding remarks

The Team-NB position paper recommends that manufacturers with an Article 61(10) device include a comprehensive discussion of non-clinical testing and how this supports conformity to the GSPR 1 and 8.  While this is not stated per the MDR, Emergo experts have had experience with at least one NB requesting this, and possibly more now with this Team-NB document. 

This position paper is a beneficial document for manufacturers and provides guidance for all devices and all CERs. The questions present the NB perspective and often, some of the rudimentary questions the reviewer wants to understand when assessing an Article 61(10) device. 

Emergo experts have successfully compiled and submitted several Article 61(10) device CERs. We welcome this insight as beneficial counsel for Article 61(10) (and Article 61(1)).