Clinical Evidence Reports (CERs) represent a key component to technical files, registration, and compliance in many countries. CERs are meant to provide a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. All of the supporting clinical evidence should be closely reviewed through a systematic critical appraisal process. The transition to MDR and IVDR in Europe has accelerated the need for up-to-date Clinical Evaluation Reports (CERs) that pass muster with multiple requirements including MedDEv 2.7/1 REV. This applies to every medical device sold in Europe irrespective of the risk classification and experience in the market. In the presentation, we will cover the nuances to meet requirements for the major countries/regions: including Europe’s Notified Bodies, Australia’s TGA, China’s NMPA, Brazil’s ANVISA, and Canada’s Health Canada. We will share about best practices and lessons learned for each of these regulatory reviews. We will also cover the new post-market surveillance requirements required by MDR that affect the CER.