Guidance

Registration of in vitro diagnostic devices with expiring CE certificates

Guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 February 2025

Documents

Registration of certain in vitro diagnostic devices

HTML

Article 110 extension confirmation template

MS Word Document, 134 KB

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

The EU has extended the validity of certain Directive 98/79/EC on in vitro diagnostic (IVD) devices (EU IVDD) certificates and declarations. This guidance sets out what this means for registration and managing registered devices in the MHRA Device Online Registration System (DORS).

Published 17 February 2025