Regulatory Compliance Services for Medical Devices

Opportunity overview

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

Awarded to

Amounts belong to published awards or contracts. Where several suppliers share one value, it is labelled as shared and is not a supplier-specific allocation.

Classification

No classification was supplied.

Lots

• Lot 1Value not stated

Documents and notices

• Contract details notice on Find a TenderOpen source ↗