TECHNICAL DOCUMENTATION CONTENT
Medical device manufacturers must have technical documentation to bring their medical devices to market. Instructions for submitting technical documents shall comply with the requirements of the (EU) 2017/745 MDR and shall include the following:
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Required items that should be included in the MDR technical document
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1.Description and specifications of medical device accessories
1-1. Device description and specifications
1-2. Reference to similar equipment previously certified
- 2.Information to be provided by the manufacturer
- 3.Design and Manufacturing Information
- 4.General safety and performance requirements
- 5.Benefit and risk analysis / risk management
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6.Product validation and validation
6-1. Preclinical trial and clinical data
6-2. Additional Information Required for Specific Cases
- 7.Post Market Surveillance Plan
- 8.PSUR (Periodic Safety Update Report)
- 9.PMS (Post-market surveillance) Report
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1.Description and specifications of medical device accessories
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