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Clinical Evaluation Report (CER)

(EU Guidance MEDDEV 2.7/1 Rev.4)

The Clinical Evaluation Report (CER) is a document which presents all the clinically relevant data collected for a particular device.

Currently, MEDDEV 2.7/1 revision 4 (Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/385/EEC) is the state-of-the-art guidance which one is expected to follow to comply with the requirements of both the Medical Device Directive (MDD) 93/42/EEC, and the Active Implantable Medical Device Directive (AIMDD) 90/385/EEC.

The Medical Device Regulation (MDR) 2017/745 clearly lays out the requirements for the CER, and although these are mostly in line with the MEDDEV guidance, there are some crucial differences one must be aware of.

The aim of the CER is to evaluate the device’s clinical safety and performance and to provide sufficient evidence that the device in question is both safe and performs as intended by the manufacturer. It will also play a vital role in determining the benefit/risk profile of the device. The manufacturer may wish to perform a clinical investigation to demonstrate these characteristics, or alternatively go down the “device equivalence” route.

The CER is complicated and should be as detailed as possible, the extent of which will depend on the device classification, its novelty, or whether it is a replacement for another version of the device already on the market.

Advena specialise in establishing and maintaining the Clinical Evaluation Plan and the Clinical Evaluation Report documentation.

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