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The journey to adoption of Europe’s Medical Device Regulations (EU MDR) begins with understanding what’s changing—and when—and then establishing whether current systems and processes are sufficient to satisfy the new regulatory requirements. With the new rules mandating the redesign of every single label being used in supply to the EU market, it appears unlikely that medical device companies will be able to rely on long-term legacy labeling systems. However, with new regulations in other key markets also coming further down the line, organizations need to make sure that future systems have in-built agility to respond to change as and when it happens.
The labeling changes mandated by EU MDR are likely to have far-reaching implications for most medical device companies. The timetable for change and the scale of the task ahead leave little room for comfort. The clock is ticking toward May 2020, when the introduction of the European Databank on Medical Devices (EUDAMED) will mean companies could be prevented from registering or re-registering their products if they don’t address associated labeling challenges ahead of time. Failure to do so could mean companies cannot market their products in Europe. Furthermore, imminent changes to regulation in key markets outside of the EU and the United States mean that companies must rethink their labeling operations or risk route-to-market or supply-chain barriers on a global scale.
The purpose of the EUDAMED is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. The European Commission has stated the importance of the EUDAMED for the functioning of the MDR and the In Vitro Diagnostic Medical Device Regulation (IVDR) in Europe. The database, which consists of seven other databases (Economic Operators, Devices, UDI, Certificates, Clinical Studies and Performance Studies, Vigilance Data, and Market Surveillance), will be accessible to competent authorities, notified bodies, industry, and the general public.
Facing a task of such magnitude, the question arises as to how organizations can achieve effective and safe change within the remaining time frame.
New Labeling Requirements
Chapter III of EU MDR, Article 23.1, stipulates that every device must be accompanied by information that identifies the device, its manufacturer, and any relevant safety/performance information. This information may appear on the device, the packaging, and the IFU. Furthermore, if the manufacturer has a Website, the information must now also be made available—and kept up to date—online.
These basic requirements, which will be rigorously enforced from May 2020, mean that, more than ever before, companies must be in control of the data they are using for their products. Historically, departments in many organizations have often maintained their own product data because they do not trust other sources. This has led to the use of multiple systems, each operating in isolation and capturing information in self-serving silos. In the example of one of the world’s largest medical device manufacturers, the organization was running no less than 30 separate labeling systems over 20 plants and 150 production lines. This approach is fraught with risk and no longer acceptable. Moreover, this traditional approach makes the cost of making a global label change very expensive.
Companies need to develop a culture of data integration and sharing. Moreover, they need to put systems in place that establish a “single source of the truth,” allowing data to be pulled from disparate systems, interfaced as a single view, and shared across the organization. The single-source approach can eradicate data duplication, inconsistencies, and costly human error. What’s more, it can significantly reduce the complexity and risks of MDR compliance.
The most progressive organizations, such as the aforementioned manufacturer, have recognized this: they know that their current labeling infrastructure is unfit for purpose and that they need to safeguard against future regulations. In addition, with major providers like Microsoft and Oracle etc. ending their support for several operating systems and databases by 2023, these companies have realized that their labeling solutions could potentially be sitting on unvalidated platforms that expose them to regulatory risk.
As a result, a growing number of medical device companies are adopting a single-touch strategy where they undergo a wholesale redesign of their global labeling processes and technology infrastructure all at once, rather than repeating the cost and disruption of additional implementations further down the line. Attack once and reduce the upcoming 2- to 4-year project cycle into 12 months.
An effective single-touch strategy can streamline processes and reduce the cost of global change by as much as 90%. For medical device companies facing a steady barrage of complex, impactful regulatory changes, the deployment of data-led labeling systems can ensure they only need to touch their labels once, whilst meeting their impending deadlines safely and effectively. The approach, which accelerates speed to market and reduces the risk of non-compliance through the efficient use of automation, also allows companies to future-proof their business as regulations and country requirements evolve over time.
The importance of selecting a labeling solution that can adapt to a changing world cannot be overstated. The best systems give manufacturers 360° visibility of all their master data assets. Moreover, by taking a data-led approach and ensuring information is available wherever and whenever it is needed, they ensure the core components of end-to-end label lifecycle management—label design, workflow, inspection capabilities, and audit control—are fully integrated and accessible across the global organization, both today and in the future.