Description:
This Clinical Evaluation Report (CER) template helps us collect, appraise, and analyse clinical evidence for a medical device to support the compliance to applicable GSPRs.

• Define the clinical evaluation scope (device, variants, intended purpose, users, patient population).
• Establish the state of the art (SOTA) and compare the device to alternatives and similar devices.
• Define and justify outcome parameters and acceptance criteria based on SOTA and similar devices.
• Assess and justify equivalence using clinical, technical, and biological criteria.
• Summarise and appraise safety and performance (S&P) evidence from clinical investigations, PMCF, literature, and PMS/vigilance/recall data.
• Evaluate the overall benefit-risk profile against SOTA.
• Determine whether there is sufficient clinical evidence to support GSPR compliance with the needs of PMCF.
• Keep traceability between CER conclusions, risk management, IFU warnings/precautions.

Key requirements covered focus on traceability and robust decision-making. SOTA is the current, accepted level of clinical and technical knowledge; it sets the benchmark for acceptance criteria and what “acceptable” means today. Equivalence is showing no clinically meaningful differences from another device across clinical, technical, and biological characteristics; it affects how much device-specific clinical data you must generate. The CER also includes a structured assessment of clinical evidence sufficiency to support compliance with the relevant GSPRs.

At Lexqara, we help you build an audit-ready CER by aligning clinical documentation, PMS/PMCF inputs, and regulatory strategy—while keeping claims evidence-based and consistent. Explore our Resource Center [https://lexqara.com/resource-center/] and Regulatory Strategy [https://lexqara.com/service/regulatory-strategy/]. For institutional context, use EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short CER gap assessment.