Bob Tilling, VP Global Sales at Kallik, understands the increase in compliance pressures facing medical device firms since 2021, and assesses the technologies that will help ease the pain of costly compliance projects.
During the rush for MDR compliance, the sheer scale of the compliance effort for medical device manufacturers doing business in the European market was a major eye-opener for many business leaders. Asset siloes were uncovered, disparate systems identified, and labels and artwork painstakingly updated – often manually, at extensive cost.
Plenty of companies operating in the medical device market are doing a great job of using technology to handle assets such as labels and artwork that require management at both the global and national levels in response to regional rules and market requirements.
But this often only extends just to simple content management instead of providing full editing, version control and re-issuing that is often required in bulk to streamline compliance projects. With more regulations being the order of the day, medical device manufacturers need to consider the bigger picture. It is clear there is more to be done for many firms in terms of addressing full digital maturity.
MDR should be seen as a wake-up call – not a one-off challenge
One Kallik client, a leading multinational medical device manufacturer, internally updated over 90,000 labels in just six months to achieve full MDR compliance – a monumental task that simply would not have been possible to achieve at scale without leveraging technology.
Yet many firms are still a long way from complying with the full extent of MDR rules such as updated product Instructions for Use (IFUs) – and the regulatory pace of change is not set to stop there. Here’s how the medical device regulatory landscape could evolve over the coming months and years – and how firms can prepare early to avoid costly, disruptive compliance burdens:
Exempt today, regulated tomorrow: The compliance scope is widening
Regulators in the EU, individual member states and further afield are all continually refining the requirements and scope of their regulations for the medical device market – both reactively in response to product deficiencies, or proactively to tighten quality and traceability.
Wider and widening still…
The scope for devices that fall under MDR for requirements such as Unique Device Identifier labels has risen significantly, expanding from roughly 2.6 million devices to five million. Coloured contact lenses, dermal fillers, medical software – even AI solutions – now fall under the regulations, leaving manufacturers scrambling to comply with unfamiliar rules.
These firms dealing in products previously exempt or outside the scope of older legislation now run the risk of an uncomfortable, short notice demand for compliance. Once regulators begin to flex their muscles and crack down on non-compliance where they identify risks, there could be significant pain on both a financial and reputational level.
Technology will be critical to meet the growing compliance burden
Regardless of how the regulatory pipeline shapes up, one lesson to be learned from the struggles witnessed during the MDR compliance push remains clear – manual solutions will be a non-starter for successive rules and regulations.
Will organisations be able to manually identify, edit and re-issue labels, artwork and packaging affected by new regulations? Certainly not without investing excessive time, capacity and finances. Adopting an end-to-end digital solution such as Veraciti will be critical to provide effortless mass asset adjustments in response to emerging regional or national regulatory shifts.
If medical device organisations act now, they will reap the long-term rewards – all while benefiting from continuous operational efficiencies and powerful new artwork and label management capabilities.