Similar to the FDA’s UDI rules, eProcurement/Scan4Safety is a government program requiring medical device manufacturers to electronically submit and maintain data records containing a large number of product attributes.2 The NHS is a regulatory agency like the FDA; however, eProcurement/Scan4Saftety is primarily a supply chain requirement for any organization wanting to be included in supply chain activities in the UK. Smiths Medical is submitting the required product data to meet the September 2019 deadline for all device classes.
There are two main similarities between NHS’s eProcurement/Scan4Safety and the FDA UDI rules: 1 – UDI and PI must be present on the label in human readable and machine readable formats, and 2 – data must be submitted through a specific channel (NHS requires a GS1 certified data pool and the GDSN, while the FDA uses the public website AccessGUDID).
There are a few key differences to be aware of between the FDA rules and NHS eProcurement/Scan4Safety:
• NHS data element requirements are more extensive than the U.S. FDA.
• NHS requires that ANYTHING that is sold into NHS be compliant with the NHS’s rules; whereas, the U.S. FDA UDI rule applies only to registered medical devices.
• NHS requires manufacturers to adopt Pan European Public Procurement Online (PEPPOL
). PEPPOL is a “messaging standard that enable key documents (purchase orders, advance shipping notes, invoices) to be electronically exchanged between buying and selling organizations without manual interventions.”
NHS Timeline
The NHS also uses a phased approach to implementation. Key dates and requirements are outlined in the table here
For the latest information on NHS eProcurement, visit the NHS Peninsula Purchasing and Supply Alliance website
.