In vitro diagnostic medical devices: guidance on legislation
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices, Patient safety, and Medical devices regulation and safety
- First published:
- 19 August 2013
Guidance explaining the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
PDF, 100KB, 15 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 firstname.lastname@example.org. Please tell us what format you need. It will help us if you say what assistive technology you use.
This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices and explains the main features of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
- the scope of the directive
- the assessment process
- in-house manufacture
For further information about the regulation of IVDs see:
Published: 19 August 2013