Description:
This Clinical Evaluation Plan (CEP) sets a clear method for planning clinical activities and clinical evidence to meet applicable GSPRs under EU MDR Article 61 and Annex XIV.

• Define the scope: device(s), variants, intended purpose, users, and patient population.
• Build state of the art (SoA) and identify similar devices and alternative treatments.
• Set outcome parameters and acceptance criteria for safety and performance.
• Justify equivalence using clinical/technical/biological characteristics.
• Plan evidence collection: literature, PMCF, PMS, and vigilance/recall inputs.

Use this CEP template when you need a practical, repeatable plan for clinical evaluation, including update triggers (design change, PMS trends, periodic review) and a clear path to a defensible CER.

It defines the key requirements for a methodologically sound clinical evaluation. SoA is the current benchmark for clinical practice and device technology; it sets what “acceptable” means. Equivalence is showing no clinically significant differences versus another device; it affects how much device-specific clinical data you need.

• Identify applicable GSPRs and link each to planned evidence.
• Define minimum clinical evidence level and justification approach.
• Specify S&P data sources and screening/appraisal rules.
• Plan benefit-risk (B/R) evaluation against SoA and acceptance criteria.
• Align with PMCF and define the clinical development plan milestones.

At Lexqara, we operationalise CEPs into controlled workflows across clinical documentation, PMS/PMCF planning, and regulatory strategy. Explore our Resource Center [https://lexqara.com/resource-center/] and Clinical Activities [https://lexqara.com/service/clinical-activities/]. Use EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short CEP gap assessment.