Richard Castle, global account manager medical device, PRISYM ID, explores the impact of the new EU MDR timeline, the challenges that medical device companies face, and what industry needs to do to achieve labelling and packaging compliance from a global perspective.
COVID-19, social distancing measures, and the obligation felt by the medical device industry to prioritise its pandemic response, have prompted the European Parliament to delay the implementation of the EU MDR for 12 months.
EU MDR, which commenced in May 2017, imposes rules on companies involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU. Its application has huge implications for labelling, introducing detailed requirements that place a key emphasis on a company’s ability to capture, manage and share data across their global organisation.
The new milestone is now confirmed for 26 May 2021, with full application of EU MDR, followed by EU Database for Medical Devices (EUDAMED) officially going live a year later (26 May 2022). Its impending enforcement presents numerous labelling challenges that could ultimately prevent organisations from being able to sell their products in Europe if they are not addressed. Organisations face the daunting prospect of changing every label and they must therefore evaluate their labelling capabilities to ensure they have the tools to manage that global change.
With the rules mandating the redesign of every single label – from symbols and warnings to location and readability - it appears unlikely that medical device companies can rely on traditional methodologies and legacy labelling systems to handle the change. Moreover, with other imminent modifications to regulation in key markets outside of the EU and US, organisations need to make sure that future systems have in-built agility to respond to change, as and when it happens.
It all means a rethink in the arenas of product data management and labelling operations. Those companies without a clear and coordinated strategy face the risk of encountering insurmountable commercial barriers.
Historically, departments in many organisations 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. This approach, which hinders compliant labelling operations, is fraught with risk and no longer acceptable. Companies need to develop a culture of data integration and sharing. They need to put systems in place that establish a ‘single source of the truth’, allowing EU MDR-compliant data to be pulled from disparate systems, interfaced as a single view and shared across the organisation.
The cost of making a global label change – using traditional processes built around multiple systems – has historically been expensive. As a result, a growing number of medical device companies are adopting ‘touch once’ strategies where they undergo a wholesale redesign of their global labelling processes all in one go, rather than repeating the cost and disruption of additional implementations further down the line. By implementing an effective and global touch once strategy, processes can be streamlined and reduce the cost of future changes by as much as 90%.
The approach, which accelerates speed-to-market and reduces the risk of non-compliance through the efficient use of automation, also allows companies to futureproof their business as regulations and country requirements evolve over time. For medical device companies facing a steady barrage of complex, impactful regulatory changes, the deployment of data-led labelling systems can ensure they only need to touch their labels once, while meeting their impending deadlines safely and effectively.
So, will the EU MDR reprieve improve labelling and packaging compliance? Yes, it could certainly help, but only for those companies who are already implementing or now considering a more holistic approach to their management of product data and labelling operations. Ideally, it’ll be through a one-touch approach, future-proofing companies in preparedness for multiple forthcoming, and perhaps as yet unforeseen, regulatory changes.
