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Notified body recommendations

Below are a list of EU Notified Body Recommendation documents for you to download:

  • Accessories Active Implantable Medical Devices
  • CE Marking of pre-MDD devices
  • Combination of CE marked and non CE marked medical devices
  • Conformity assessment procedures of breast implants
  • Content of mandatory certificates
  • EMC requirements
  • Evaluation of clinical data
  • Explanation of Terms
  • Guidance on clinicals
  • Homogeneous batches
  • Medical devices with a measuring function
  • Placing on the market of fully refurbished medical devices
  • Post-Marketing Surveillance
  • Renewal of EC Design-Examination and Type-Examination Certificates
  • Reporting of design changes and changes of the quality system
  • Representative Sample
  • Subcontracting QS related
  • Technical Documentation
  • Translation procedure
  • Treatment of computer used to program AIMD
  • Use-by date for Medical devices
  • Voluntary certification at an intermediate stage of manufacture

Documents correct as of 12/11/04, please check the  European Commission's Website for the most up to date versions.

For more information about Notified Body recommendations, please Contact Us.

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