Guidance

Registration of reusable or upclassified Class I devices and/or expiring CE certificates

Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.

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

Documents

Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates

HTML

Article 120 extension confirmation template

MS Word Document, 131 KB

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Details

The EU has extended the validity of certain Directive 93/42/EEC on medical devices (EU MDD) and Directive 90/385/EEC on active implantable medical devices (EU AIMDD) certificates. 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