Introduction to Clinical Evaluation Reports (CER) for Europe

Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device, creating and maintaining a Clinical Evaluation Report (CER) can be a complex and resource intensive task.

The CER is a major portion of the Technical File and is required for all medical devices regardless of classification. Even simple Class I device requires a CER! The Clinical Evaluation is exactly what it sounds like – an evaluation of research done on the safety and efficacy of the device. That research might have been done by your company, or published by others, and depending on the risk category of your device it can be fairly simple or quite extensive.

In this video we'll explore the different aspects of a CER including what it is, why it is needed, an overview of the research process, and finally its contents and formatting.

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Are you interested in selling your medical device in the European Union, but are not sure how to go about meeting the Medical Device Directives' quality standards? You will be pleased to know that EN ISO 13485 meets most of the QMS requirements outlined in the Directives, which is why many medical device companies choose to implement it before entering the European medical device market.