Transcription of Technical Documentation Requirements under MDR
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Technical Documentation Requirements under MDR
1 Technical Documentation Requirements under MDR (including Requirements for legacy files) Dr Amie Smirthwaite clinical Oversight and Training Lead BSI Notified Body 2 Topics Overview of Technical Documentation Requirements New Requirements ? clinical investigations and equivalence Reclassifications 3 Overview of Technical Documentation Requirements 4 MDR Requirements for Technical Documentation 1: Device description 2: Information to be supplied by the manufacturer 3: Design and manufacturing information 4: General safety and performance Requirements 6: Product verification and validation 5: Benefit-risk analysis and risk management Annex II: Technical Documentation 5 MDR Requirements for Technical Documentation 1: Device description 2: Information to be supplied by the manufacturer 3: Design and manufacturing information 4: General safety and performance Requirements 6: Product verification and validation 5: Benefit-risk analysis and risk management Annex II: Technical Documentation Annex III: Technical Documentation on Post-Market Surveillance 6 MDR Requirements for Technical Documentation 1.
Clinical Investigation Chapter VI, Annex XV Postmarket Surveillance, PSUR and vigilance Chapter VII . 7 MDR Requirements for technical documentation ... •Clinical evaluation report and plan •PMCF plan and evaluation report •Specific validations for devices incorporating medicinal substances, animal or human
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