Guidance

In vitro diagnostic medical devices: procurement, safety, quality and performance

Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 July 2005
• Last updated: 28 January 2021
  Show all updates

  1. 28 January 2021

     Uploaded a new PDF to reflect the changes to regulations following Brexit transition.

  2. 22 July 2005

     First published.

Documents

Management of in vitro diagnostic medical devices

PDF, 887 KB, 20 pages

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This guidance on IVDs is aimed at all staff who are responsible for purchasing, supplying, using, maintaining and replacing IVDs. This includes staff such as:

• pathology managers
• scientists
• technical and clinical staff in all disciplines of pathology laboratories
• purchasers