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, including benefit-risk evaluationFrequent notified body findings AcronymsReferences and related . Introduction and backgroundThere has been significant evolution in the European regulatory landscape over the past 10 15 years, particularly with respect to requirements for Clinical evaluation .
Data appraisal and analysis ... Table 1: Timeline of regulations and guidance impacting clinical evaluation assessments from 2009–present ... evaluation is ‘to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer’.
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