Guidance

In vitro diagnostic medical devices: guidance on legislation

Explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices (IVDs).

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

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). 

You should read it in conjunction with vigilance guidance for IVDs and advice for UK approved bodies on self-tests.

It covers:

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

Updates to this page

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.

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