Technical File Template - IVDR (EU 2017/746) ISO 9001 Procedure Maintain Identification: Ensure medical devices

Maintain Identification: Ensure medical devices are identified by suitable means throughout production

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the condition of the product

Design and Development Stages: Clearly defining each stage of the design and development process

and specifications are complete and accurate

Technical File Template - IVDR (EU 2017/746) ISO 9001 Procedure Maintain Identification: Ensure medical devicesMedical Device File Template In Vitro Diagnostics (EU 2017 746) This medical device file template is set out to meet the requirements set out in Annex II and Annex III of the In Vitro Diagnostic Device Regulation EU 2017 746 for documentation required to demonstrate conformity to the regulations. Device Description Labelling Design and Manufacturing GSPRs Risk Management Verification & Validation Post Market Surveillance If you would like further