Source: https://tendernation.io/opportunities/01a13be2-06e0-703f-94cc-5810d549ec6c/regulatory-compliance-services-for-medical-devices awarded GB negotiated without publication procedure # Regulatory Compliance Services for Medical Devices [NHS England](https://tendernation.io/buyers/nhs-england) Estimated value Not stated Published 19 Jun 2026 Deadline Rolling deadline ## About this tender 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 Source Find a Tender (UK) · Notice ocds-h6vhtk-06b95e-2026-06-19T15:03:16+01:00 [View official notice](https://www.find-tender.service.gov.uk/Notice/ocds-h6vhtk-06b95e-2026-06-19T15:03:16+01:00) Never miss a tender like this again Get AI summaries, deadline alerts and a bid pipeline for tenders matched to your business. Free to start. [Track tenders free](https://tendernation.io/register) [Buyer profile NHS England: past awards and live tenders](https://tendernation.io/buyers/nhs-england) ## More tenders like this [Bannister Sports Centre Athletic Track Soft Market Testing Exercise · Harrow Council · 38 days left · 26 Nov 2026](https://tendernation.io/opportunities/01a1540d-d9e4-71cb-ad57-1603e9042fec/bannister-sports-centre-athletic-track-soft-market-testing-exercise) [Engineering works and construction works – Integrated Partnerships Framework · Northern Ireland Water · 30 days left · 18 Nov 2026](https://tendernation.io/opportunities/01a156a9-7b9a-73c9-b710-2a5021d3fa0d/united-kingdom-engineering-works-and-construction-works-integrated-partnersh) [Hdc-1714 wadkins pavilion refurbishment · Harborough District Council · 39 days left · 27 Nov 2026](https://tendernation.io/opportunities/01a155bf-f664-72f9-9823-a85d6cddbdc6/hdc-1714-wadkins-pavilion-refurbishment) [Design, supply, and Installation of Newbiggin Skatepark Extension · Newbiggin Town Council · 35 days left · 23 Nov 2026](https://tendernation.io/opportunities/01a15552-19a2-7348-a5cc-3f5ae51ef934/design-supply-and-installation-of-newbiggin-skatepark-extension) [Tender for the design, supply, delivery and installation of a modular UNIT and associated works at ARC healthy living, irvinestown. peaceplus funded upgrade works · Fermanagh and Omagh District Council · 14 days left · 2 Nov 2026](https://tendernation.io/opportunities/01a15552-1b74-73ec-a6f6-a1af37959997/tender-for-the-design-supply-delivery-and-installation-of-a-modular-unit-and-a) [Architectural, design and building consultancy services - Dalby Visitor Centre · Forestry Commission · 25 days left · 13 Nov 2026](https://tendernation.io/opportunities/01a15552-1b8a-7041-80fb-e4943876fc38/architectural-design-and-building-consultancy-services-dalby-visitor-centre)