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
📌 Clinical Evaluation (India)
🏢 Meril
📍 India