Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards. The more at the stake, a more detailed significant report is mandatory for a device. ![]() ![]() CER is a major portion of the technical file even though it is a stand-alone document and is required for all medical devices regardless of classification. Based on the device’s risk category, the Clinical Evaluation Report can be simple or quite extensive. Launching a new medical device in the market always need a Clinical Evaluation Report to submit to the EU Market as per the European Union’s Medical Device Regulation (MDR) introduced in May 2017. Share this article: A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission
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