FOCUS: Clinical evaluation of your medical device

Clinical evaluation is a mandatory step in the process of obtaining CE marking for a medical device.

This systematic step consists of continuously producing, collecting, analyzing and evaluating clinical data in order to verify the safety and performance of a device . Clinical data is information relating to safety and performance obtained in the context of the use of a device.

This information may come from various sources such as:

• Clinical investigations
• Scientific publications
• Post-marketing surveillance (SAC/PMS) in particular post-marketing clinical monitoring (SCAC/PMCF).

The data can come from the device concerned but also from a device whose equivalence can be demonstrated.

The challenge in clinical evaluation is to determine the quantity and quality of clinical data needed to assess whether the device is safe and provides the expected clinical benefit(s).

Also, not all clinical data have the same weight. Indeed, the results obtained by a clinical investigation carried out on the device being evaluated will have more importance than data from pre-clinical tests or data from similar device(s). This is particularly shown to us in the European guide MDCG 2020-6 . This guide focuses on the clinical evidence required for CE marked devices under Directive 93/42/EEC (legacy device). Its Annex III presents a table with the type and weight of clinical data. The clinical evidence required for the conformity assessment is defined in the clinical development plan. The latter can be included in the clinical evaluation plan.

The evaluation plan is accompanied by a report. While the first defines the method of clinical evaluation and the state of the art, the second presents the results of the research of clinical data and allows to conclude on the safety and performance of the device studied. The details of the content of the plan and the report are presented in Annex XIV Part A of European Regulation (EU) 2017/745 .

Today, the standards used for clinical evaluation do not include all the requirements of the new European regulation, but they provide a basis for carrying out the evaluation and the parties that must be present.

The guides mainly used in the clinical evaluation of medical devices are as follows:

• Meddev 2.7/1 Revision 4 dated June 2016 “Clinical evaluation: Guide for manufacturers and notified bodies”. To date, it is the most important reference for the clinical evaluation of medical devices.
• The IMDRF MDCE WG/N56FINAL:2019 guide dated October 2019: “Clinical Evaluation”. The table in Appendix F of this guide is particularly used for the weighting of scientific articles.
• The Team NB Position Paper published in April 2023: “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”. The “clinical evaluation” part of the document includes the requirements of the regulation with explanations. This guide also details the expected requirements regarding post-market surveillance (PMS/SAC), post-marketing clinical follow-up (PMCF/SCAC), the Summary of Safety Characteristics and Clinical Performance (SSCP) as well as the requirements that should appear if a clinical investigation has been conducted.

Further requirements regarding post-market surveillance are available through other guides:

• For PMCF/SCAC: MDCG guides 2020-7 and 2020-8 provide a model plan and report.
• For SSCP: MDCG 2019-9 Rev 1 provides detailed explanations on this topic as well as a template that can be used.

Regarding clinical investigations , the EN ISO 14155:2020 standard is one of the references for conducting a clinical investigation. The list of documents cited here is not exhaustive, there are indeed other guides and other references. Nevertheless, the documents presented here represent a basis for carrying out the clinical evaluation process necessary to obtain CE marking for medical devices.

In the future, clinical assessment could become a standardized process . Indeed, a draft standard is currently being prepared concerning clinical assessment: the ISO 18969 standard. It should be available for public inquiry in February 2024 for publication by the end of 2025.