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Clinical and Performance Evaluation under EU-MDR – New CE Market Rules

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The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device in its clinical use. As a part of the conformity assessment procedure to obtain the CE marking it is an important process. Apart from the MDR, there are some guidelines/standards that must be observed when creating a clinical evaluation, such as the MEDDEV 2.7/1 Rev. 4 (2016), MDCG 2020-5 and 2020-6 or requirements from the ISO 14155.

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_1_guidance_clinic_eva_md_software_en.pdf

https://www.regulatory-affairs.org/en/clinical-affairs/news-page/clinical-evaluation-of-medical-devices-mdr0/