Checklist: Take a close look at your clinical data!
When it comes to the approval of medical devices, the Clinical Evaluation Report (CER) is always a key element. It could be described as the heart of the design dossier. Even the smallest weakness might prove fatal in the conformity assessment. To make sure you are on the safe side, TÜV SÜD’s Global Clinical Focus Team has prepared a checklist that will help you with the preparation of your clinical data. The checklist is based on the requirements of the European Medical Device Regulation (MDR) and MEDDEV 2.7.1 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” for the CER and all relevant clinical data.
Are your clinical data complete?
Make sure to verify the completeness and correctness of your clinical data at an early stage. The checklist ‘Customer Clinical Evidence, Validation Checklist of Clinical Evidenceis’ available for free download here: