Last week’s UDIs and Traceability for Medical Devices conference in Amsterdam highlighted some of the key developments in UDI implementation and alignment across regulatory, supply chain and customer environments as we move one year closer to the EU MDR. We had the opportunity to hear from and engage with key speakers and delegates from some of the leading medical device companies, as well as our own CEO, Neil Gleghorn who delivered a very well received presentation on how embracing UDI can create a more connected digital labelling enterprise.
As UDI regulations begin to mature across the EU and US, countries including India, China and South Korea are beginning to adopt a similar strategy. From this, it is highly likely that there will need to be multiple iterations of labelling for the same products in order to meet these evolving requirements. Healthcare providers (including the NHS) will also be looking for specific labelling content to meet their individual procurement and supply chain requirements.
Dennis Black, Director of e-Business Solutions Group, BD provided some interesting insights around this. Dennis believes that regulators and providers should work towards a global, harmonised approach but recognises that this may not be entirely possible. The impact of not doing so is the cost and the risk of errors being introduced each time a market specific or provider specific requirement needs to be captured on the label. The ultimate risks being non-compliance with regulatory requirements with the result of losing valuable contracts with healthcare providers.
A recent study carried out by McKinsey & Co. demonstrates just what can be achieved by having better connected systems and processes. These include reduced time to market and inventory costs of between 20-50% and an increase of 45-55% in productivity. It must be advised that changes to labelling alone will not deliver these figures, but without addressing the challenges around disconnected labelling systems and processes, we predict it’s likely that these figures would diminish.
So, how does this impact medical device labelling? Organisations must be able to adapt quickly to labelling changes driven by the evolving maturity of UDI. This will ensure they don’t lose out to competitors that may have more dynamic systems in place. The FDA acknowledged that they are now sharpening their focus on data quality, and specifically, addressing the need for accurate labelling data uploads to their UDI database (GUDID). This is in the interest of ensuring that patients, having received an implantable, or who are using medical devices, receive accurate and transparent information relating to their use, manufacture and authenticity. This applies equally, whether reading from a printed label, manufacturer’s webpage or searching the GUDID.
A subject that was widely discussed at the conference was that of ‘Basic UDI-DI’. As part of the MDR, a Basic UDI-DI is being introduced. This refers to the relationship between what is a family of products that may otherwise appear to be unique individual products e.g. if one product in a family has manufacturing defects and needs to be recalled, the Basic UDI-DI shows this relationship. The basic UDI-DI itself doesn’t appear on the label but an organisation must be able to identify all other related products as a result of querying the UDI on the label via the EU UDI database (EUDAMED). This relationship is something that medical device manufacturers will need to capture and make available for on-demand searches by patients, providers and notified bodies with the ask made much simpler by connecting previously disparate labelling processes.
The challenge for many organisations is that they lack the tools, systems and processes to be able to dynamically identify and update product labelling in suitable timescales. All, of course, whilst retaining fluidity, compliance and avoiding disruption of supply chains.
This is where Kallik’s ‘where used’ function can really help. At the press of a button, it allows any authorised user to quickly locate one or more product families from one single identifier (i.e. the Basic UDI-DI).
Are you interested in finding out how Kallik can prepare your organisation for the upcoming EU MDR as well as simplify compliance with the Basic UDI-DI? Get in touch with our labelling and artwork management experts here and/or visit our resources page for more insights.