The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance. Device claims are a part of the advertising and promotion of a product which, in the European Union, are regulated by MDR 201/745, along with several EU directives, and the legislations of the individual EU Member States. The substantiation or disproval of claims is to be carried out as part of the conformity assessment of a device and are required to be done by way of a clinical evaluation.
The results of the clinical evaluation and the clinical evidence on which they are based must be captured in a Clinical Evaluation Report (CER).
This article explores the requirements for medical device claims and the clinical evaluation process for device conformity. You can access the article here.
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