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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 periods for Technical Documentation 8 Summary from the MDD/AIMDD to the MDR.

the technical documentation should be developed and handled. As mentioned in the first paragraph from Annex II of the MDR, ‘the technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the

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