# 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

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the sale and supply of in vitro diagnostic (IVD) medical devices within Great Britain. This document outlines the regulatory framework established under Part IV of the UK Medical Devices Regulations 2002 (as amended), which governs how these devices are assessed and marketed. Because this is a general guidance document rather than an enforcement notice, it does not pertain to a specific company or individual inspection dates, nor does it list specific violations. Instead, it defines the scope of the regulations and details the mandatory assessment processes that manufacturers must follow to ensure product safety and effectiveness. A significant focus is placed on the requirements for in-house manufacture, providing clarity for healthcare institutions that develop their own diagnostic tools. Required actions for manufacturers include verifying that their products meet the necessary safety standards, completing the appropriate conformity assessment procedures, and ensuring all technical documentation is up to date. Compliance with these regulations is essential for any entity looking to distribute IVDs in the British market, as non-compliance may result in regulatory intervention or the suspension of product sales.

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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)