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whether youre a multinational medical device conglomerate working on the eighth generation of your device or a small device manufacturer struggling to market your first product creating and maintaining a clinical evaluation report can be a complex and resource intensive task [Music] in this video well explore the different aspects of a CER including what it is why it is needed an overview of the research process and finally its contents and formatting before obtaining seee marking in the EU medical device manufacturers must prove to the competent authority that their device meets safety and performance standards the medical device directive requires the manufacturer to perform a clinical evaluation of their device the clinical evaluation is exactly what it sounds like an evaluation of research done on the safety and efficacy of the device that research might have been done by your company or published by others and depending on the risk category of your device it can be fairly simple