Clinical Evaluation Report & Plan Templates
CER + CEP (10% off)
The 73-page Clinical Evaluation Report (CER) Template and the associated 55-page Clinical Evaluation Plan (CEP) Template contain all the required sections, and follow the European Union (EU) Medical Device Regulation (MDR) 2017/745-approved organization as recommended by the Medical Device Coordination Group (MDCG) 2020-6 guidelines. The Notified Body (NB) expects these recommendations to be implemented in any CEP and CER for a clinical evaluation of a medical device on the EU market.
These templates assist manufacturers in the development of both CERs and CEPs that are complete, free from ambiguity, well organized, and easy to review. They are easy to use, clean and concise, free from notorious errors and formatting issues, and have built-in automated features for fast and efficient generation of comprehensive CERs and CEPs. Clear guidance in each section as well as extensive example texts, (partially filled) tables, and diagrams allow authors to immediately focus on the medical device-specific content, and take off with a flying start.
Download a read-only PDF sample of the first 18 pages of the CER template here: CER Template PDF sample
Watch short, 1-minute tutorial videos that explain all features of the templates and proper MS Word usage to retain the robustness and resilience of these documents when circulating for review.