Guidance

Electronic instructions for use of medical devices: guidance on regulations

Guidance for medical device manufacturers on when electronic instructions for use can be used.

Documents

Guidance on the regulations for electronic instructions for use of medical devices

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Details

This guidance covers:

  • definitions
  • applicable types of device
  • conditions
  • risk assessment
  • requirements for the electronic labelling
  • website provision
  • notified bodies
Published 14 March 2013