Learning the lessons to avoid the nightmare
PRISYM IDís Mark Cusworth examines the EU Medical Device Regulation and its implications for labelling ó and looks ahead to a future that could become a nightmare unless companies act now. Imagine waking up in a world in which the product registrations of all your medical devices have become invalid. Itís a world in which you need to reregister every device that you plan to ship to Europe. And, worse still, itís a world wherein that reregistration process dictates changes to the labelling content of all those devices ó from the product artwork to the literature that accompanies it.
Itís a nightmare scenario, isnít it? A cold sweat moment. But it will soon become a reality for all medical device manufacturers that do business in Europe. New medical device regulations (MDRs) are now in place that impose major requirements on anyone involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU. Although full adoption is not expected until 2020, many of the most challenging requirements need to be in place by December 2018.
EU MDR is broad-ranging regulation that replaces the old EU Medical Device Directive and subjects the entire product lifecycle to new and comprehensive scrutiny. Its scope is forcing medical device companies ó and their external partners ó to review processes and systems that touch every aspect of their operations. The ramifications for labelling operations are particularly significant, shining a bright light on organisationsí ability to capture, manage and share data across their entire enterprise.
The first major milestone of the adoption timetable is the introduction of the new European Database for Medical Devices (EUDAMED), which goes live next December. This development alone is the catalyst for a wave of labelling challenges that could prevent businesses from being able to sell their devices in Europe if theyíre not addressed in time. MDR mandates that product registrations for all devices need to be submitted to EUDAMED if theyíre to be permitted for sale in the EU.
However, to register products successfully, companies must comply with new and specific requirements for labelling content. These include, but are not limited to, labelling requirements for single-use devices, clinical investigation, hazard warnings, electronic labelling, electronic IFUs (instructions for use) and the future introduction of mandatory symbols.
One particular requirement ó the introduction of a new symbol to show that a package contains a medical device ó means that every company will need to amend their label design to allow for its inclusion. The regulation also heralds the introduction of UDI (unique device identifier) requirements for all medical devices. Although many of these changes are in line with US UDIs, there are significant differences that mean its EU counterpart will be applied to more devices and adopt tighter controls than FDA.
These are huge, impactful changes that dictate the need for a data-led labelling system and infrastructure that provides connectivity, visibility and control right across a company. However, a recent industry survey indicates that only half the industry has understood the implications of the regulations and begun to plan for change. Worryingly, of the remaining half that havenít, 48% admit theyíve not yet started to think about the challenge. Itís a risky game; the countdown to December 2018 has already begun.
Naturally, the introduction of UDI requirements to the EU means that many organisations are already some way along the pathway of adopting processes that support FDA UDI compliance. So, what can we learn from the US experience that might inform best practice adoption in the EU? Here are five key learnings that have emerged:
Act now: Itís easy to underestimate the impact that UDI implementation will have on operations ó and the cross-organisational involvement such projects demand. As a result, development and deployment can become slow, complex and expensive. However, the scope of MDR is far broader than UDI, bringing greater complexity and more impactful penalties if systems fail to comply.
There is no greater penalty than the inability to ship product whilst companies await a license. So, lesson one is simple: donít wait, act now ó the commercial ramifications of failure are huge.
Itís not just about labelling: UDI is commonly misconceived as the sole preserve of the labelling or regulatory department. But, just like labelling itself, it touches every aspect of a business. Itís therefore important to ensure that the development of systems to support MDR compliance is based on the views of all relevant stakeholders ó not simply single-discipline functions. The most successful companies build integrated teams that involve stakeholders from both within and outside of the organisation. Crucially, they establish them early ó and engage them frequently ó to help shape a collaborative strategy.
Test your systems: Before considering a new implementation, itís important to test your existing system; sometimes, it may have capabilities that youíre unaware of and are going to waste. Similarly, some solutions make functionality claims that donít reflect the real-world experience. For example, many solutions promise a single source of the truth; but, poor integration with other systems makes it difficult for users to access and retrieve data. The lesson? Conduct fit-for-purpose tests on your software and hardware ó and if youíre uncertain about capabilities, talk to your technology partner.
Ensure data are reliable: Having a reliable single source of the truth has never been more important; MDR mandates that organisations include data from every part of an enterprise on their labelling and packaging. Yet, many companies still donít have sufficient confidence in their data. Understanding and trusting your data model is key to a successful implementation. Itís important to know where your data is stored, how itís maintained and what controls are in place to ensure its integrity. The best solutions allow users to capture data compliantly but also to maintain it in ways that meet the needs of all stakeholders.
Be ready for change: Operational agility is a vital commodity. The regulatory landscape tomorrow will look different to that of today, so itís important to think long-term and build solutions that flex as the regulatory environment evolves. Companies often deploy systems that focus on narrow, present-day requirements, only to find themselves straitjacketed when the landscape inevitably shifts. Think bigger picture and continually collaborate, both internally and externally. A good technology partner will design systems based on a deep understanding of the industry and be cognizant of the fluctuating regulatory environment.
Ultimately, the best labelling solutions give medical device organisations a 360į view of their master data assets. And they ensure the core components of label lifecycle management ó label design, workflow processes, inspection capabilities and audit control ó flow naturally together. These capabilities will be essential if companies are to meet the requirements of EU MDR. But the countdown has already begun. The demands of December 2018 will soon be upon us. Act now to avoid the nightmare.