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

By Heather Crawford and Evangeline Loh

Background on Team-NB position paper

Team-NB has released a position paper (April 21) on non-clinical data and the application of Article 61(10) of the Medical Device Regulation 2017/745 (MDR). While manufacturers may view this is only for devices considering an Article 61(10) strategy, this document is a useful guide for Clinical Evaluation Reports (CERs).

Team-NB distinguishes between Article 61(10) devices and Article 61(1) devices. In either case, both devices require a compiled CER and need to be supported by a well-developed post-marketing surveillance system (PMS). In addition, the Notified Body (NB) would assess the applicability of Article 61(10) on the many facets of the intended purpose, more below, and the CER. 

Article 61(10) devices

Article 61(10) devices are devices where compliance on clinical data (safety and performance generated from use of the device) is not applicable based on many considerations. The Position Paper defines non-clinical data sources which may be applicable once a device is defined as Article 61(10): simulated use, animal, cadavers, pre-clinical bench testing and compliance to standards, and performance evaluation, in vitro, ex vivo, in silico, computational modelling and pre-clinical evaluation. 

The paper opines that the manufacturer’s retorts of “clinical data is not available” or “clinical data is difficult to generate” are not appropriate as the rationale for Article 61(10). 

General guidance for medical device manufacturers

The position paper describes the importance of developing and defining the intended purpose. References are provided to further support the intended purpose statement, including MEDDEV 2.7/1, Rev. 4. Once this has been done, and with the General Safety Performance Requirements (GSPRs), the manufacturer defines 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.

In particular, for each defined parameter, the manufacturer needs to determine if the corresponding measurement method is clinical, or for Article 61(10), non-clinical, according to the SOA. The SOA helps to support whether it would be appropriate to use a non-clinical method to support the parameter.

Three specific areas of NB review

In particular, the NB document identifies three criteria for assessment of Article 61(10) devices: intended clinical performance and claims, interaction between the device and human body and risk management. 

In all three of these areas, there are a series of questions in which the NB qualifies whether the response would make the device more likely as Article 61(10) or Article 61(1). Again, while this paper is titled Article 61(10), these questions are beneficial for all manufacturers compiling CERs.

Concluding remarks

Our next regulatory update will discuss the three assessment criteria and related questions in greater detail.

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)).