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Technical Documentation and Medical Device Regulation

Technical Documentation and Medical Device RegulationA Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745Dr Julianne Bobela, Project Associate; Dr Benjamin Frisch, Senior Associate; Kim Rochat, Senior Partner; and Michael Maier, Senior Partner; all at Medidee Services SAiiTechnical Documentation and Medical Device RegulationContentsIntroduction 1 Transition to the new legislation 1 Compiling the Technical Documentation 2 Content of the Technical Documentation 4 Other Technical Documentation requirements 5 Post-market surveillance plan 6 Conformity assessment review of Technical Documentation 7 Person responsible for regulatory compliance 8 Requirements related to authorized representatives 8 Archiving

Technical Documentation and Medical Device Regulation latest in 2024. Manufacturers of class I devices, which are not provided sterile, have no measurement function and are not reusable surgical instruments, will also need to update their technical documentation in …

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