Transcription of Clinical evaluation under EU MDR
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Clinical evaluation under EU MDR
Clinical evaluation under EU MDRA uthor - Dr. Amie Smirthwaite, Global VP for Clinical Services, RMQ+2 Clinical evaluation under EU MDRC ontentsIntroduction and backgroundPurpose of a Clinical evaluationOverview of the Clinical evaluation processClinical evaluation planning Intended purpose, indications, contraindications Intended/expected Clinical benefit Clinical claims Duration of use Establishing the SOTA and benchmarks for safety and performance Purpose of the SOTA evaluationDevices with direct Clinical benefits Devices with indirect, broad or generic Clinical benefitsThe rest of the Clinical evaluation process Data collectionData appraisal and analysisData mapping and conclusions.
2014 NBOG BPG 2014-2 2016 MedDev 2.7/1 rev 4 Further expansion of the guidance, to reinforce concepts around quality and completeness of clinical data and scientific validity of conclusions (increase from 46 to 65 pages) 2017 Regulation (EU) 2017/745 Clinical evaluation requirements largely aligned with
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