EU Medical Device Regulations - The nightmare before Christmas
Imagine waking up in a world where the product registrations of all your medical devices have become invalid. It’s a world where you need to re-register every device that you plan to ship to Europe. And, worse still, it’s a world where that re-registration process dictates changes to the labelling content of all those devices – from the product artwork to the literature that accompanies it. This will soon become a reality for all medical device manufacturers that do business in Europe.
New medical device regulations (MDR) 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.
Out with the old, in with the new
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 – and their external partners – 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 organizations’ 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 December 2018. 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 they are not addressed in time.
MDR mandates that product registrations for all devices need to be submitted to EUDAMED if they’re to be permitted for sale in the EU. However, to register products successfully, companies must comply with new and specific requirements around labelling content. These include, but are not limited to, labelling requirements around: single-use devices, clinical investigation, hazard warnings, electronic labelling, electronic IFUs and the future introduction of mandatory symbols.
One particular requirement – the introduction of a new symbol to show that a package contains a medical device– means that every company will need to amend their label design to allow for its inclusion. The regulation also heralds the introduction of UDI requirements for all medical devices. Though many of these changes are in line with US UDI, there are significant differences that mean its EU counterpart will be applied to more devices and adopt tighter controls than the 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 haven’t, 48% admit they’ve not yet started to think about the challenge. The countdown to Christmas 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.
Five gold rings
#1: Act now
It’s easy to underestimate the impact that UDI implementation will have on operations – 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. Lesson one is simple: don’t wait, act now – the commercial ramifications of failure are huge.
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#2: It’s 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. It’s therefore important to ensure that the development of systems to support MDR compliance is based on the views of all relevant stakeholders – not simply single-discipline functions. The most successful companies build integrated teams that involve stakeholders from both across and outside of the organisation. Crucially, they establish them early – and engage them frequently – to help shape a collaborative strategy
#3: Test your systems
Before considering a new implementation, it’s important to test the existing system – sometimes it may have capabilities that you’re unaware of which are going to waste. Similarly, some solutions make functionality claims that don’t reflect the real-world experience. For example, many solutions promise a ‘single source of the truth’ but poor integration with other systems make it difficult for users to access and retrieve data. The lesson? Conduct ‘Fit for Purpose’ tests on your software and hardware – and if you’re uncertain about capabilities, talk to your technology partner.
#4: Ensure data is reliable
Having a reliable ‘single source of the truth’ has never been more important; MDR mandates organisations to include data from every part of an enterprise on their labelling and packaging. Yet many companies still don’t have sufficient confidence in their data. Understanding and trusting your data model is key to a successful implementation. It’s important to know where your data is stored, how it’s maintained and what controls are in place to assure 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.
#5: Be ready for change
Operational agility is a vital commodity. The regulatory landscape tomorrow will look different to what it does today – so it’s important to think longer-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 organizations a 360° view of their master data assets. And they ensure the core components of label lifecycle management – label design, workflow processes, inspection capabilities and audit control – flow naturally together. These capabilities will be essential if companies are to meet the requirements of EU MDR. But the countdown to Christmas future has already begun. The demands of December 2018 will soon be upon us. Act now to avoid the nightmare before Christmas.
Further information can be accessed via Prisymid’s whitepaper.