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Guidance

In vitro diagnostic medical devices: guidance on legislation

How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
19 August 2013
Last updated:
15 January 2025
Show all updates

  1. Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  2. In vitro diagnostic medical devices: guidance on legislation file updated.

  3. This page has been updated due to the end of the Brexit transition period.

  4. Added a link to new guidance on medical devices regulation in a no deal scenario.

  5. First published.

Documents

In vitro diagnostic medical devices: guidance on legislation

PDF, 355 KB, 19 pages

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Details

This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices in Great Britain and explains the main features of the requirements for IVDs, set out in Part IV of the UK Medical Devices Regulations 2002 (as amended) (UK MDR 2002). 

It covers:

  • the scope of the UK MDR 2002
  • the assessment process
  • in-house manufacture

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