---
title: "Regulatory Compliance Services for Medical Devices"
ocid: "ocds-h6vhtk-06b95e"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-06b95e"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-06b95e.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-06b95e.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "NHS ENGLAND"
published: "2026-06-19"
---

# Regulatory Compliance Services for Medical Devices

Buyer: NHS ENGLAND  
Current stage: Award  
OCID: ocds-h6vhtk-06b95e

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[Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-06b95e.json)

## Summary

NHS England is spearheading a procurement process to secure Regulatory Compliance Services for Medical Devices, located in London. The procurement falls under the health services category, and the project has reached the award stage. This initiative seeks to engage a UK Approved Body to perform dual-stage audits facilitating ISO 13485 certification. This certification is critical to comply with evolving regulations that reclassify several medical devices to higher-risk status in 2026. The procurement process followed a limited method under the threshold with a focus on specific, urgent needs. The contract was signed on 2nd June 2026 and is set to complete by 31st March 2027.

This tender represents a significant opportunity for businesses operating within the healthcare compliance sector, specifically those capable of conducting rigorous audits and ensuring product safety and regulatory adherence. It is particularly suited for organisations with expertise in regulatory affairs and quality management systems, like SCARLET GLOBAL HOLDINGS LTD, which won the contract. The procurement underscores a growing demand for compliance services necessitated by new regulations, opening doors for specialist firms to collaborate with key health authorities and expand their footprint in a critical area of public health services.

## Notice

The procurement covers regulatory compliance services for medical devices, specifically the engagement of a UK Approved Body to conduct a two-stage external audits (Stage 1 and Stage 2) in line with agreed timelines, to urgently achieve ISO 13485 Quality Management System certification. The deliverables will ensure that our medical devices are safe, effective, reliable and meet internationally recognized standard. With the UK medical device regulations set to change in Spring 2026, several currently self-certified, low-risk SaMDs will be reclassified as higher-risk devices. This means external certification by a UK Approved Body (e.g., BSI) will become mandatory. Failure to achieve this will result in an "innovation freeze," preventing the introduction of new or updated SaMDs and AIaMDs, and exposing NHS England to significant legal, reputational, and operational risks. This is not a discretionary activity--it is a statutory obligation

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/058183-2026 |
| Notice type | UK7 - Contract Details Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Limited |
| Procurement method details | Below threshold - limited competition |
| Tender suitability | Not specified |
| Awardee scale | Large |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 19 Jun 2026 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | 1 Jun 2026 |
| Contract period | 1 Jun 2026 - 31 Mar 2027 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | £75,000 |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Complete |
| Awards status | Active |
| Contracts status | Active |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | NHS ENGLAND |
| Locality | LONDON |
| Post town | South East London |
| Postcode | SE1 8UG |
| Country | England |
| ITL 1 | TLI London |
| ITL 2 | TLI4 Inner London - East |
| ITL 3 | TLI45 Lambeth |
| Local authority | Lambeth |
| Electoral ward | Waterloo & South Bank |
| Westminster constituency | Vauxhall and Camberwell Green |
| Delivery location | Not specified |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | SCARLET GLOBAL HOLDINGS |

## CPV Codes

### Divisions

- 85 - Health and social work services

### Codes

- 85100000 - Health services

## Release History

- 19 Jun 2026 at 14:03 - Award - UK7 - Contract Details Notice - https://www.find-tender.service.gov.uk/Notice/058183-2026

## Documents

- https://www.find-tender.service.gov.uk/Notice/058183-2026
  19th June 2026 - Contract details notice on Find a Tender

## Notice URLs

- https://www.england.nhs.uk/
- https://www.legislation.gov.uk/ukpga/2023/54/contents

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-06b95e. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-06b95e.json.