Clinical Evaluation Plan
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.What this means in practice
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.- •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.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsIVDR equivalent of PMCF - ongoing collection of performance data for in vitro diagnostics.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
Good clinical practice for clinical investigations of medical devices.
IVDR Essentials
· From this learning pathAnnex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
Mandatory European conformity mark for medical devices placed on the EU market.
IVD that identifies patients who will benefit from a specific drug.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Primary references
3 sources- 1
EU MDR Annex XIVVerifiedEUR-Lexeur-lex.europa.eu
- 2
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
- 3
ICH GuidelinesVerifiedICHich.org
Inline markers like [1] jump to the matching reference above.