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Regulations and Guidance

FDA, NHS eProcurement, Scan4Safety, EUMDR AND Others

The FDA was the first entity to require product data in a public database. At first, many manufacturers used spreadsheets to push information to the GUDID. As more regulators and organizations require electronic product data, Smiths Medical has expanded our system to accommodate machine-to-machine data transmission. Smiths Medical works with 1WorldSync, a data pool provider, to make GDSN-compliant data available to customers and regulatory groups. This collaboration uses machine-to-machine technology for both GDSN and FDA.


FDA’s UDI Final Rule and GUDID

The FDA published its final rule in the Federal Register in 2013 establishing a system for UDI and GUDID.6 The FDA rule requires manufacturers selling into the U.S. to include UDIs in both plain text and barcode formats on medical device labels and packages and submit product data to the GUDID,  available online. Certain combination packs/kits and devices licensed under the Public Health Service (PHS) must also comply with the UDI rule.

The FDA believes these requirements will:

• Reduce medical errors.

• Simplify the integration of device use information into data systems.

• Provide for more rapid identification of medical devices with adverse events, more rapid development of solutions to reported problems, more efficient resolution of device recalls, and more focused and effective FDA safety communication.

FDA UDI Timeline

The FDA used a phased approach for their final rule.7 Key dates and requirements are outlined in the table here

Please see the FDA website for more information about the final rule and UDI compliance.

NHS eProcurement and Scan4Safety

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.

EU MDR and EUDAMED



The European Union Medical Device Regulation (EU MDR) was published April 5, 2017 and represents a significant update to the previous regulation, the EU Medical Device Directive (MDD).   UDI barcode and product data requirements are key components moving forward. As the industry implements this regulation, “maintenance of data will characterize the era of EU MDR” (http://eumdr.com/eudamed/). EU MDR requirements include an electronic UDI system and submission to EUDAMED, Europe’s database that will store product data using GS1 standards. EU MDR’s UDI and data requirements are scheduled to take effect in 2020.

The amount of data which will be available to the European Authorities in the future is one of the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR).


www.eumdr.com

MDR Timeline

The timeline for implementing EU MDR is still evolving, but these key dates have been identified.

References

8. The New Regulations on Medical Devices. European Commission website. Accessed on 11 Oct 2018 at: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en