# In vitro diagnostic medical devices: guidance on legislation

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/52f4d0b1-8666-453b-a93e-dc7b10d03ec5
Type: Guidance
Published: August 18, 2013
Updated: January 15, 2025

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

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## Content

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

## Attachments

- [In vitro diagnostic medical devices: guidance on legislation](https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf)