With system to clinical evaluation according to MDR

It is indispensable for manufacturers of medical devices of all risk classes: The clinical evaluation according to MDR. According to Regulation (EU) 2017 / 745 (MDR) and as part of the conformity assessment procedure, documentation is a prerequisite for successful market access and must be planned.

As part of the technical documentation, the clinical evaluation is the basis for a safe medical device. The legal requirements are all the greater for this. But what exactly is the purpose of the clinical evaluation?

Above all, it is systematic proof that the medical device meets basic safety and performance requirements. The side effects that patients must expect and the consequences that can be ruled out are also documented in the clinical evaluation. It thus serves as evidence of a justifiable risk-benefit ratio.

Good to know:

A common misconception: Class I devices do not need a clinical evaluation. This is wrong, because every medical device is bound by the requirements of the MDR. Even if the Notified Body does not carry out a clinical evaluation test for Class I devices, an evaluation must still be available on request.

Systematic to clinical evaluation

So how do you create a clinical evaluation? Above all, the preliminary work is crucial: First, you have to plan the process and the requirements for the product and develop a strategy for obtaining clinical data. You can obtain this data via studies from scientific literature research. Clinical trials are also suitable.

This process is part of the technical documentation. This means: All steps of the clinical evaluation must be planned and recorded in a report.

CEP and CER – what is that?

The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers have proceeded in the preparation of the clinical evaluation.

Clinical Evaluation Scope & Plan (CEP):
- Includes essential safety and performance requirements that must be supported by relevant clinical data.
- Requires specification of the intended purpose of the device and a target population with indications and contraindications.
- serves as a detailed description of the intended clinical benefit for patients
- formulates relevant clinical outcome parameters and a clinical development plan
Clinical Evaluation Report (CER):
- serves as a report of the course of action planned in the CEP
- contains all relevant information on the safety, performance and clinical benefit of the medical device
- is based on Article 61 of the MDR

Important: Over the lifetime of the product, the documents must be continuously updated using PMCF data.

The continuous and regular updating of the clinical evaluation after the medical device has been placed on the market is also part of the Post Market Clinical Follow-up (PMCF).

BAYOOMED’s experts support you in all phases of a clinical evaluation. Simply make an appointment for an initial consultation.

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With system to clinical evaluation according to MDR

Systematic to clinical evaluation

CEP and CER – what is that?

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