Guidance

In vitro diagnostic medical devices: guidance on legislation

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 19 August 2013
• Last updated: 17 July 2023 — See all updates

Documents

In vitro diagnostic medical devices: guidance on legislation

PDF, 295 KB, 18 pages

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Details

Please note that this guidance is in the process of being updated.

This guidance is specific to in vitro diagnostic devices placed on the market in Great Britain (England, Wales and Scotland). For guidance on the legislation applicable to in vitro diagnostic medical devices in Northern Ireland, please see our published guidance.

This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices and explains the main features of Part IV of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

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 UK MDR 2002
• the assessment process

• in-house manufacture

Published 19 August 2013
Last updated 17 July 2023 + show all updates

1. 17 July 2023

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

2. 31 December 2020

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

3. 26 February 2019

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

4. 19 August 2013

   First published.