Keeping clinical evaluation documentation complete, traceable, and audit-ready is one of the most demanding aspects of EU MDR compliance. The Clinical Evaluation File (CEF) template is built to make that manageable.
Aligned with Regulation (EU) 2017/745 Annex XIV, MEDDEV 2.7/1 Rev. 4, MDCG 2020-5, MDCG 2020-6, and MDCG 2020-13, this template brings together the core documents of clinical evaluation — the Clinical Evaluation Plan (CEP), Literature Search Protocol (LSP), Literature Search Report (LSR), Demonstration of Equivalence (DOE), and Clinical Evaluation Report (CER).
The CEP defines the scope, intended purpose, target population, and methodology. The LSP defines the search strategy and the LSR documents the identified literature, which is subsequently appraised through a dedicated process before being consolidated in the CER. The DOE supports equivalence justification where applicable. The CER brings all clinical data together, documents the state of the art, and presents a concluded benefit-risk determination demonstrating conformity with Annex I requirements.
This template is built by experienced regulatory professionals, giving manufacturers a reliable, audit-ready foundation, without the complexity of building a compliant clinical evaluation file from scratch.
Price: $3000 $2400 (20% off)
Template Preview
Loading PDF...
FAQ:
A Clinical Evaluation File (CEF) is a structured set of documents used to demonstrate the safety, performance, and clinical benefit of a medical device under EU MDR 2017/745.
The template includes the Clinical Evaluation Plan (CEP), Literature Search Protocol (LSP), Literature Search Report (LSR), Demonstration of Equivalence (DOE), and Clinical Evaluation Report (CER).
Yes. The template is aligned with Regulation (EU) 2017/745 Annex XIV, MEDDEV 2.7/1 Rev. 4, MDCG 2020-5, MDCG 2020-6, and MDCG 2020-13 guidance documents.
Request Regulatory & QMS Templates
Select the templates you need and our team will get back to you with details.
Template Purchase Enquiry
Share your requirements and we'll guide you through the next steps
