What is Clinical Evaluation Equivalence and does that apply to your medical device?

Are you considering substantiating the clinical data of your device based on an equivalence device? Do you have full access to clinical data for technical, biological and clinically similar devices and you wish to leverage that to prove compliance for another device?  This article could help you get a feeling of whether this could be an option.

Understanding MDCG 2020-5

MDCG 2020-5 Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies was published in 2020 with the aim to contribute to clarifying the best practices with regard to the possibility of using clinical data for equivalent devices. As the guidance explains, clinical investigation is the most straight forward approach to compile clinical data to substantiate general safety and performance.

However, the option to provide data (gained through clinical investigation or scientific literature) of a medical device for which equivalence to the medical device in question can be demonstrated, must be structured in line with the Medical Device Regulation 2017/745 (MDR) requirements. Note that the demonstration of equivalence does not make compilation of a compliant clinical evaluation redundant. Clinical evaluation is how potential equivalence can be substantiated. Also, when claiming equivalence, actual data (clinical evaluation or technical documentation of the other device) to which you refer must be fully available.

Furthermore, this guidance explains the differences between the previously available MEDDEV 2.7/1 rev 4 (under the directives 93/42/EEC and 90/385/EEC) and the MDR when describing what actually is considered as equivalence with respect to the technical, biological and clinical characteristics in a straight forward manner which is helpful to consult when assessing whether you can apply this option.

Breaking down equivalence: Technical, biological, and clinical characteristics

Note that all required characteristics must match within one single device and cannot be in multiple devices. But what does this actually mean? MDCG 2020-5 summarizes this as follows:

• Technical characteristics hint to matters such as similar design and same conditions of use, similar properties (specific to the device such as algorithms and deployment methods (for software), wavelength, surface characteristics (hardware)), the performance requirements and principle of operation.
• Biological characteristics reflect factors such as the material and substances that come into contact with human tissue and body fluids, whether there is degrading materials (ISO 10993) and the device (with substances) is absorbed or dispersed in the body (Annex I to Directive 2001/83/EC). Finally, it refers to the ancillary medicinal substances which will require same medicinal substance and related excipients/coatings including the effect on release characteristics and clinical performance.
• Finally, the clinical characteristics which refer to equivalence in safety and clinical performance, clinical conditions or purpose (with respect to the severity and stage of the disease), clinical performance and consideration of modifications which includes justification for safety and performance improvements and absence of additional risks or altered performance due to modifications.

Practical next steps 

Finally, since this guidance document provides useful information for the Notified Bodies as well, you can get a sense of where you can put more focus on. Do not forget to fill in Annex I – Equivalence table of this guidance! It will definitely reflect whether or not this approach might be an option. Focus on justification of the equivalence and provide the information as clear and complete possible.

As a Notified Body, we see and understand the challenge of compiling clinical data, the timelines and resources required to gain such data in a compliant and useful manner! If this happens to be applicable to you as manufacturer and you doubt whether your device fulfills the requirements above, then start the exercise by filling in Annex I – Equivalence table of MDCG 2020-5.