Role Purpose
Lead the end-to-end clinical evaluation and clinical evidence strategy for Class III implantable medical devices in compliance with Regulation (EU) 2017/745 (EU MDR). Own the preparation, review, approval and lifecycle maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), ensuring robust clinical evidence and alignment with post-market surveillance, risk management and product claims.

Key Responsibilities
· Lead preparation, review and periodic update of CEP and CER in accordance with EU MDR Article 61 and Annex XIV Part A, applying MEDDEV 2.7/1 Rev. 4 methodology as appropriate.

· Define clinical evidence strategy and assess clinical safety, performance, clinical benefit, benefit-risk acceptability, intended purpose, indications, claims and State of the Art (SOTA).

· Plan and oversee systematic literature searches, screening, critical appraisal, data extraction and analysis of clinical investigations and scientific literature.

· Establish objective safety and performance acceptance criteria/benchmarks,



including acceptable rates or thresholds for adverse events, reliable adverse events, device-related complications and undesirable side-effects, based on SOTA, relevant literature, clinical data and benefit-risk considerations.

· Apply appropriate statistical methods to evaluate adverse-event rates and determine/justify acceptance thresholds, including as applicable incidence/proportion estimates, confidence intervals, comparator or benchmark analysis, hypothesis testing, survival/time-to-event methods and trend analysis. Ensure statistical methods, assumptions and thresholds are scientifically justified and documented in the CEP/CER.

· Assess whether observed adverse-event and complication rates remain within predefined acceptance criteria and evaluate their impact on residual risk and benefit-risk acceptability.

· Determine whether clinical evidence is sufficient, identify evidence gaps, and define required PMCF an

📌 Clinical Evaluation (Killa-pardi)
🏢 Meril
📍 Killa-pardi