# Registration of in vitro diagnostic devices with expiring CE certificates

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/071c0a56-2253-469a-a163-b10b12ccccd4
Type: Guidance
Published: February 17, 2025

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

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## Content

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).

## Attachments

- [Registration of certain in vitro diagnostic devices](/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices)
- [Article 110 extension confirmation template](https://assets.publishing.service.gov.uk/media/67b308e9b56d8b0856c2fd40/EU_IVDR_Article_110_extension_confirmation_template.docx)
