CER Requirements and Expertise

According to MEDDEV 2.7/1 Rev.4, “Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to analyse whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use”.

Clinical evaluation is a responsibility of the manufacturer and is conducted throughout the life cycle of a medical device, as an ongoing process. Usually, it is first performed during the development of a medical device in order to identify data that need to be generated for market access. Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter.

Clinical evaluation is an element of the technical documentation of a medical device and the requirements for this evaluation apply to all classes of medical devices. The evaluation should be appropriate to the device under evaluation, its specific properties, and its intended purpose.

The stages of the clinical evaluation process are demonstrated in the image below.

Why do you need us?

Although the clinical evaluation process demands a lot of scientific knowledge in order to understand the clinical context of the device, the evaluator needs to possess a lot more skills like designing the right question to identify the right evidence for the device, being in constant touch with the evolving regulatory requirements and excellent writing skills to put the whole clinical evaluation report (CER) together.

We, at iPharmedservices, have a strong expertise in Post-Market Surveillance (PMS), Clinical Evaluation, Biological Evaluation as well as the EU Technical file activities and have assisted our clients in CE-marking of the products for the European market. With a strong expertise built over the years, we not only author your reports, we will also ensure that they are current, complete and robust.

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