Clinical Evaluation Report

Clinical Evaluation Report (CER)

Dr Klinisch research provides support in the creation of a new clinical evaluation report as well as updating existing clinical evaluation. We can assist with:

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analysed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.

Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File.

Clinical Evaluation Reports is prepared as per Annex XIV, Part A of Regulation (EU) 2017/745. According to MDR:

To plan, continuously conduct and document a clinical evaluation, manufacturers shall:

Establish and update clinical evaluation plan.

Identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic literature review.

Appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device.

Generate through properly designed clinical investigation in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues.

Analyse all relevant clinical data in order to reach conclusion about the safety and clinical performance of the device including its clinical benefit.

The clinical evaluation should be thorough and objective, and take into account both favourable and unfavourable data.

A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated.

The results of the clinical evaluation and the clinical evidence on which it is based should be documented in a clinical evaluation report which support the assessment of the conformity of the device.

How to prepare a Clinical Evaluation Report for medical devices

A clinical evaluation takes place in three steps:

A list of possible elements to include in your CER is as follows:

When to update your device CER

The initial report is just the beginning of your CER’s lifecycle. Update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:

• Every year, or:
• When you receive new information from post-market surveillance that could change the current evaluation, or:
• Every two to five years if the device is not expected to carry significant risks and is well established.

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