The European Union Medical Device Regulation (EU MDR 2017/745) has introduced rigorous requirements for the clinical evaluation of medical devices. Article 61(10) specifically addresses scenarios where clinical data is not deemed appropriate for certain devices. This whitepaper explores the requirements under Article 61(10), the types of data that can be used to support compliance, and practical examples of devices that might qualify under this provision. Additionally, we will discuss considerations for the Clinical Evaluation Report (CER) and the implications of Article 7 for device claims.
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