Change of https://www.gov.uk/government/publications/custom-made-medical-devices

Change description : 2025-06-16 10:00:00: Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024. [Guidance and regulation]

Showing diff : 2025-01-15 10:05:27.771609333 +00:00..2025-06-16 09:03:32.781617440 +00:00

Guidance

Custom-made medical devices in Great Britain

How to comply with the regulatory requirements for manufacturing custom-made medical devices.

From:
Medicines and Healthcare products Regulatory Agency
Published
16 August 2013
Last updated
1516 JanuaryJune 2025 — See all updates

Documents

Custom-made devices in Great Britain

HTML

Examples of statements for custom-made medical devices

PDF, 268 KB, 7 pages

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Details

Guidance for manufacturers on how to comply with the legal requirements for custom-made active implantable medical devices and custom-made medical devices.

This Informationinformation also explains what a custom-made device is and gives examples.

Updates to this page

Published 16 August 2013

Last updated 1516 JanuaryJune 2025 + show href="#full-history">+ show all updates

    3. Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

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Update history

2026-07-20 09:06
Updated to clarify registration requirements for custom-made devices

2025-06-16 10:00
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

2025-01-15 10:00
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.