Guidance

In vitro diagnostic medical devices: guidance on legislation

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

Document

In vitro diagnostic medical devices: guidance on legislation

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Details

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:

Published 19 August 2013