Regulatory Compliance Services for Medical Devices
Buyer: NHS England
- Published
- 19 June 2026
- Estimated value
- £75,000
- Procedure
- Direct award
- Lots
- 1
- Notice number
- 058183-2026
- Reference
- ocds-h6vhtk-06b95e
- Official source
- Official source
CPV codes
- 85100000Health services
Description
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
Awards
| Awarded to | Amount | Date |
|---|---|---|
| SCARLET GLOBAL HOLDINGS LTD | — | — |
Official publications
- FTS · 058183-2026 · 19 June 2026
Other tenders from NHS England
- Soft Skills Course for GP IMGs (2026-2031)
- National Gambling Helpline
- Leadership Development to Support Engagement and Learning for Harmed Families
- Master’s Level Paediatric Audiology Modules Lot 2
- NHS National Framework for Lenvatinib
- Agenda for Change Job Evaluation Digital System
- Professional and Generic Skills Programme
- Prescription Exemption Checking Service (PECS) 2026/2027
- Dental exemption checking service (Decs) 2026/2027
- PCS National Assurance for Primary Care Contractor 2026-27
Frequently asked questions
- What is the estimated value of this tender?
- The estimated value published by the buyer is £75,000.
- Who is the buyer of this tender?
- The contracting authority is NHS England (United Kingdom).
- How can I bid for public tenders in the United Kingdom?
- Bids are submitted through the official public procurement portal in the United Kingdom. El Vínculo helps you find tenders and analyse their documents; submission always happens at the official source.
Create a free account and receive new public tenders published in the United Kingdom that match your business, every day.