Clinical & Trials
Clinical Evaluation Plan(CEP)
In one line
EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
Definition
A Clinical Evaluation Plan (CEP) is a structured planning document required under EU MDR (Annex XIV Part A §1(a)) that defines how the manufacturer will conduct the clinical evaluation of a medical device. The CEP identifies the device and its intended purpose, the equivalence claim (if any), the clinical development stages, the data sources to be evaluated (clinical investigations, literature, post-market data), the acceptance criteria for clinical performance and safety, the benefit-risk methodology, and the plan for ongoing clinical evaluation through PMCF. The CER documents the execution of the CEP.
Why it matters
Under MDR, the CEP is the upfront commitment that disciplines the entire clinical evaluation process, Notified Bodies review the CEP for adequacy before accepting a CER. A weak or generic CEP is one of the most common causes of MDR clinical evaluation deficiencies. MDCG 2020-13 provides the CER assessment template that Notified Bodies use, and it is essentially scoring CER conformance against the CEP.
Common pitfalls
- •Writing a generic CEP that doesn't actually scope the clinical evaluation, Notified Bodies will issue major deficiencies.
- •Skipping the equivalence rationale in the CEP and then claiming equivalence in the CER, must be planned upfront.
- •Failing to align the CEP with the PMCF plan, they are intended to form a continuous evidence loop.
Sources
- EU MDR Annex XIV · EUR-Lex
- ClinicalTrials.gov · NIH
- ICH Guidelines · ICH