# Medical devices: list of UK approved bodies

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/11a9dba0-18c6-4ffd-8d51-e2f0cfe36aeb
Type: Guidance
Published: January 1, 2021
Updated: December 18, 2025

> This MHRA guidance document provides a comprehensive list and description of organizations designated as Approved Bodies under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), also known as the UK MDR 2002. These bodies are authorized to perform essential conformity assessments for medical devices to ensure they meet stringent safety and quality standards before being placed on the market in Great Britain. While the provided text serves as an introductory overview and does not list specific company violations, inspection dates, or enforcement actions, it reinforces the regulatory framework governing medical technology. The primary requirement for manufacturers is to ensure their devices undergo the mandated assessment process by an appropriate Approved Body as dictated by the UK MDR 2002. By adhering to this framework, manufacturers can achieve compliance and secure the necessary certification for their products. The guidance acts as a critical reference for stakeholders to identify valid assessment partners and understand the legal prerequisites for device commercialization within the United Kingdom's healthcare sector.

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## Content

This information provides details of the bodies that have been approved under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for the assessment of medical devices required by the regulations.

## Attachments

- [Intertek Medical Notified Body UK Ltd medical devices scope](https://assets.publishing.service.gov.uk/media/691d8b34e39a085bda43ef48/Intertek_Medical_Notified_Body_UK_Ltd_Medical_Devices_Scope.pdf)
- [Scarlet NB UK Ltd medical devices scope](https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf)
- [SGS United Kingdom Limited in-vitro diagnostics medical devices scope](https://assets.publishing.service.gov.uk/media/61040d938fa8f5042aecd46a/Document_4_AB_SGS_0120_Invitro_Diagnostic_Medical_Devices_Scope_June2021.pdf)
- [SGS United Kingdom Limited medical devices scope](https://assets.publishing.service.gov.uk/media/62829451e90e071f62029ba5/AB_SGS_0120_Medical_Devices_Scope_May_2022_b.pdf)
- [TUV Rheinland UK limited in-vitro diagnostics medical devices scope](https://assets.publishing.service.gov.uk/media/64d4c5a9667f340014549d56/AB_TUV_RH_2571_Invitro_Diagnostic_Medical_Devices_Scope.pdf)
- [TUV Rheinland UK Limited medical devices scope](https://assets.publishing.service.gov.uk/media/64d4c540667f340014549d54/TUV_Rheinland_UK_Limited_Medical_Devices_Scope.pdf)
- [BSI Assurance UK Ltd active implantable medical devices scope](https://assets.publishing.service.gov.uk/media/69402676adb5707d9f33d7a6/AB_BSI_0086_Active_Implantable_Medical_Devices_Scope__Dec_2025.pdf)
- [ BSI Assurance UK Ltd in-vitro diagnostics medical devices scope](https://assets.publishing.service.gov.uk/media/694026766a12691d48491fe7/AB_BSI_0086_In_Vitro_Diagnostic_Scope_Dec_2025.pdf)
- [BSI Assurance UK Ltd medical devices scope](https://assets.publishing.service.gov.uk/media/694026766a12691d48491fe8/AB_BSI_0086_Medical_Devices_Scope_Dec_2025.pdf)
- [DEKRA Active Implantable Medical Devices Scope  ](https://assets.publishing.service.gov.uk/media/6830b90da599d03a16bff500/DEKRA_Active_Implantable_Medical_Devices_Scope_May25.pdf)
- [DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope](https://assets.publishing.service.gov.uk/media/677ea2add721a08c006655a8/AB_DEKRA_8505_IVD_SCOPE_Dec_2024.pdf)
- [DEKRA Certification UK Ltd medical devices scope ](https://assets.publishing.service.gov.uk/media/67b4be3cb56d8b0856c2fe97/DEKRA_Certification_Ltd_Medical_Devices_Scope_Feb25.pdf)
- [Eurofins E&E CML Limited medical devices scope ](https://assets.publishing.service.gov.uk/media/680b46d7bc942a09683a27a4/AB_Eurofins_Medical_Devices_Scope_April_2025.pdf)
- [TUV SUD BABT active implantable medical devices scope](https://assets.publishing.service.gov.uk/media/65b7843bc5aacc0013a6842a/AB_TUV_SUD_Active_Implantable_Medical_Devices_Scope_Dec_23_updated.pdf)
- [TUV SUD BABT Unlimited In-Vitro Diagnostic Medical Devices Scope](https://assets.publishing.service.gov.uk/media/6867bbbd2557debd867cbcbb/TUV_SUD_BABT_Unlimited_In-Vitro_Diagnostic_Medical_Devices_Scope.pdf)
- [TUV SUD BABT Unlimited medical devices scope](https://assets.publishing.service.gov.uk/media/64db6998c8dee4000d7f1ca2/TUV_SUD_BABT_Unlimited_Medical_Devices_Scope.pdf)
- [UL International (UK) Ltd in-vitro diagnostics medical devices scope](https://assets.publishing.service.gov.uk/media/65de0367b8da630011c86301/UL_Scope_IVDs.pdf)
- [UL International (UK) Ltd medical devices scope](https://assets.publishing.service.gov.uk/media/6735d2a537aabe56c416111a/UL_Scope_Medical_Devices.pdf)
- [List of UK approved bodies for medical devices](/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices)