What is compliance?

Scan4Safety is driving change across the NHS and its supplier base through the use of published timelines setting out compliance milestones for each stakeholder group. For suppliers, Scan4Safety has published a timeline for medical and in-vitro diagnostic and medicines manufacturers.

Whilst the current scope of Scan4Safety’s supplier engagement covers all medical and in-vitro diagnostic devices, all categories and services within the supply chain will eventually be in scope for compliance.

All suppliers of Medical and In-Vitro diagnostic devices should have:

• Completed the Department of Health and Social Care’s Supplier Readiness Survey.
• Allocated a GS1 GLN (location identifier) for your company.
• Allocated a GS1 product identifier to your products. You will need to allocate a unique GTIN (Global Trade Item Number) to each packaging level.
• Joined a PEPPOL Access Point, allowing you to enter and transact electronic messages with the NHS.
• Completed the Department of Health and Social Care’s Statement of Commitment to the adoption of GS1 and PEPPOL standards.

How is compliance measured?

The Department of Health and Social Care undertakes regular and robust assurance processes to assess levels of compliance amongst NHS suppliers.

There is a ‘Compliance Self Declaration Questionnaire for Medical and In – Vitro Diagnostic Device Suppliers’ that is to be completed with reference to the relevant compliance timeline for industry. This ongoing process provides suppliers with the opportunity to state compliance against the relevant milestones.

Allowing suppliers to update their compliance on a continuous basis via the questionnaire enables DHSC to have an improved view of industry’s compliance status. Reporting of results will be undertaken quarterly in February, May, August and November.

For suppliers interested in becoming part of this compliance process, a guidance document on completing the questionnaire is available on DHSC eXchange. The Department of Health and Social Care encourages all suppliers to the NHS to join the supplier eXchange workspace, email a statement of commitment to the programme, and to complete the self-declaration.

Progress of suppliers to the NHS

See the progress made by suppliers to the NHS here.

If you do not have access to the Department of Health and Social Care’s Workspace, please send an email to Scan4Safety@dh.gsi.gov.uk to request access.