{"id":4404,"date":"2021-08-05T03:45:00","date_gmt":"2021-08-05T03:45:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4404"},"modified":"2025-12-03T06:06:21","modified_gmt":"2025-12-03T06:06:21","slug":"clinical-and-performance-evaluation-under-eu-mdr-new-ce-market-rules","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/clinical-and-performance-evaluation-under-eu-mdr-new-ce-market-rules\/","title":{"rendered":"Clinical and Performance Evaluation under EU-MDR – New CE Market Rules"},"content":{"rendered":"\n

Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device. That way, it also verifies the safety and performance including the clinical benefit of a device for its intended use just as indicated by the manufacturer. In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD. The clinical evaluation is part of medical device development and must comply with the general safety and performance requirements (GSLA) so that the device can be approved, and CE marked. This means that every medical device manufacturer has to go through this process with his device.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Clinical evaluation and the MDR<\/strong><\/h3>\n\n\n\n

The clinical evaluation is regulated in MDR section 61 and annex XIV, the term on its own is also defined in the general definitions. The transition from MDD to MDR also has some impact on the clinical evaluation, but the clinical evaluation should continue to be created based on existing clinical data.<\/p>\n\n\n\n