The 56-page Clinical Evaluation Plan (CEP) Template and the associated 80-page Clinical Evaluation Report (CER) 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.
The 27-page Summary of Safety and Clinical Performance (SSCP) Template is required for all Class III and implantable devices per the EU MDR 2017/745. It contains a section for healthcare professionals as well as a section for patients, and follows the structural layout as recommended by the MDCG 2019-9 guidelines and as expected by the NB. This SSCP template is designed for easy transfer of information from the finalized CER, with clear references to where the information can be found and how this should be edited in the SSCP.
The 43-page Post-Market Clinical Follow-up Plan (PMCFP) Template and the associated 43-page Post-Market Clinical Follow-up Report (PMCFR) Template are compliant with the EU MDR 2017/745 required content and section order per the MDCG 2020-7 and 2020-8 guidelines. These templates are designed to strategize and document post-market clinical data collection in support of the clinical evaluation of a medical device on the EU market.
The 23-page Literature Review Protocol (LRP) Template and the associated 31-page Literature Review Report (LRR) Template are specifically designed as part of the clinical evaluation process to complement the CEP and CER for EU MDR 2017/745-compliant submissions to the NB. In addition, this package includes three MS Excel Literature Assessment Worksheets to collect, select, assess, and appraise the literature in a convenient and organized manner.
These clinical evaluation templates assist manufacturers in the development of CEPs and CERs that are complete, free from ambiguity, well organized, and easy to review. They are straightforward 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 CEPs and CERs. 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 19 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.
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