The CER (Clinical Evaluation Report) is one of the key documents required to be prepared for the clinical evaluation of medical devices. This is a continuous process that is required throughout the entire life cycle of a medical device to get approval and obtain CE (Conformité Européenne) marking, thus ensuring a positive benefit-risk profile of the product. To be compliant with EU-MDR and other applicable standards, a Technical File Gap Analysis for the medical device should be performed. Medical device companies need to develop a robust literature, identify predicate devices in the market, analyze the clinical and performance review process, and obtain additional data from the post marketing surveillance of the device. The dynamic MDR regulations are more stringent than those of MDD and compliance with MDR requirements often poses challenges for the medical device companies to introduce their products into the market and maintain them through the lifecycle of devices.
The white paper focuses on the type of documentation required throughout the lifecycle of medical devices, their timelines, and the need to prepare high-quality documentation to adhere to the changing guidelines to get quicker regulatory approvals.