To be able to determine whether the product complies with the European legislation or not, the manufactures of the medical devices are required to provide Technical Documentation. This includes any documentation that relates to the product’s conformity, starting with:

  • Device description and specification (e.g. UDI, risk class, technical specifications etc.)
  • Information regarding the labels and packaging.
  • The instructions for use.
  • Information regarding the manufacturing processes.
  • Information regarding all production sites.
  • Documentation demonstrating compliance with the general safety and performance requirements.
  • The benefit-risk analysis.
  • Documentation on all test results and analyses.
  • Documentation on (pre-)clinical data.
  • Quality Management System