Technical Documentation Requirements under MDR
Technical Documentation Requirements under MDR
(including requirements for legacy files)
Dr Amie Smirthwaite Clinical Oversight and Training Lead BSI Notified Body
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Topics
? Overview of Technical Documentation Requirements ? New requirements? ? Clinical investigations and equivalence ? Reclassifications
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Overview of Technical
Documentation Requirements
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MDR Requirements for technical documentation
Annex II: Technical Documentation
1: Device description
2: Information to be supplied by the manufacturer
3: Design and manufacturing information
4: General safety and performance requirements
5: Benefit-risk analysis and risk management
6: Product verification and validation
4
MDR Requirements for technical documentation
Annex II: Technical Documentation
1: Device description
2: Information to be supplied by the manufacturer
3: Design and manufacturing information
4: General safety and performance requirements
5: Benefit-risk analysis and risk management
6: Product verification and validation Annex III: Technical Documentation on Post-Market Surveillance
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