Guidance explaining the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.

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This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices and explains the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.

It should be read in conjunction with vigilance guidance for IVDs and advice for notified bodies on self-tests.

It covers:

  • the scope of the directive
  • the assessment process
  • in-house manufacture

For further information about the regulation of IVDs see: