Clinical Evaluation of Medical Devices: Feedback from the Field

In October 2023, we at Cisteo began offering clinical evaluation services.

In nearly three years, we've completed quite a few projects.

In this article, we would like to share our insights based on observations we frequently make regarding medical device manufacturers, regardless of their level of experience in preparing technical documentation.

No or limited clinical data available = application of Article 61(10) of the MDR 2017/745: false!

As Team-NB’s recent position paper on this article points out, some manufacturers choose this certification route not because nonclinical testing can demonstrate the product’s performance, but rather because the performance evaluation is poorly documented or lacking altogether—and they view it as a “miracle” solution!

This might come as a surprise to you, but that's not how it works.

The line of reasoning to follow is as follows:

• Does my device provide direct or indirect clinical benefits?
• Are my performances clinical or purely technical?

Please note: If your device is a Class III device or an implantable device, this route is not available.

For further information, we recommend reading Team-NB’sPosition Paper, as well as the 2023 GMED newsletter and the 2026 BSI article, which present concrete examples of how this is applied.

In our experience—particularly with manufacturers of Class IIa devices that have received nonconformity notices from their notified body—the main issue concerns the state of the art.

The observed causes include:

• The transition from Class I to Class IIa under Regulation (EU) 2017/745;
• The in-depth “desk review” of the literature, which highlights gaps in the clinical strategy.

As a reminder, the state of the art reflects the current state of scientific and medical knowledge regarding the device and its field. It must therefore be updated regularly.

To help you organize it effectively, here are a few key questions:

• Which diseases or conditions are involved?
• What are the causes, symptoms, and risk factors?
• Are there different stages of development?
• What is the target population for this disease (age, gender, etc.)? What technology does my device use? How does it work?
• Are there any similar programs? If so, which ones?
• Are there any alternatives (including medication)? What are their advantages and disadvantages?

Whenever there is a change in the state of the art, it is necessary to ask these same questions again. Any change in the answers may constitute a significant change requiring an impact analysis or even notification to your notified body.

Following on from the discussion of Article 61(10), preclinical data must be:

• documented,
• usable,
• and actually put to use.

We frequently observe:

• reports that are unsigned or undated,
• insufficient or unjustified sampling,
• the absence of objectives, acceptance criteria, or conclusions.

Under these circumstances, it becomes difficult to assess whether performance has been demonstrated or whether regulatory requirements have been met.

Message to R&D teams: If a test is conducted to validate a performance metric or requirement, this must be clearly stated in the report, including:

• a specific goal,
• acceptance criteria,
• an explicit conclusion.

A handwritten calculation sheet or a simple photo without any context does not constitute admissible evidence, either for regulatory teams or for the notified body.

In this article, we wanted to share some insights drawn from our professional experience.

Although these situations are rare, they often involve manufacturers that are in the process of restructuring.

Don't hesitate to ask for help!