The Medical Device Regulation (MDR) - A Blessing or a Curse?
Clinical data, documentation, unique device identification (UDI), MDR – the Medical Device Regulation (2017/745/EU) – is an important European Union regulation in force since May 26, 2021. In replacing the previous Directive 93/42/EEC on Medical Devices (MDD), it introduces even stricter requirements and more comprehensive controls.
The prime objective of the MDR is to increase patient safety while, promoting innovation in medical technology at the same time. But nevertheless, the big question remains: is it really possible to promote innovation with so many regulations? Does the MDR leave any room for creative solutions? WEINMANN also senses this uncertainty.
The Transition Process at WEINMANN
The initial process of transitioning from MDD to MDR was punctuated with many questions marks. For example, how do we understand the new requirements? The many discussions about how to interpret the requirements led to uncertainty. Even consulting firms and notified bodies had to gather experience first themselves. Frequently, new doubts about solutions were expressed. Ole Tobian, Head of Quality Management – Supply Chain, was Project Manager at WEINMANN R & D back then and responsible for the introduction of UDI, among other MDR-related issues. “We had to re-design many processes and procedures in order to meet the new requirements. On the one hand, this was good because we were forced to streamline things that would have been lost in the day-to-day operations. On the other hand, many people were frustrated because other important topics fell to the wayside.”
Stifling for Innovative Product Development
The MDR places severely high demands on processes in clinical evaluations, technical documentation and risk management. The additional steps are time-consuming and cost-intensive. For small and medium-sized companies, this means that the resources they would otherwise invest in the development of innovative products are spent on compliance with regulations. More extensive documentation ties up resources that are then not available for research and development. This stifles innovation. Samir El Diwany, Head of Ventilation Product Management, is all too familiar with such frustration from his team: “The strict requirements of MDR hinder us in our work by narrowing the playing field for creative and innovative product developments. The regulation deprives us of the opportunity to bring life-saving products to market quickly and efficiently."
Challenges in Emergency Medicine
André Schulte, CEO of WEINMANN, emphasizes the special challenges facing products in emergency medical services: “Operational situations are difficult to compare in studies, and the external conditions are not as stable as in the clinical setting. That makes it particularly difficult for us.” Ole Tobian sees documentation as the main challenge: “With older, but well-received devices, the time expended on paperwork no longer makes sense. As a result, WEINMANN has had to remove products from its range.” Kristin Ratschiller, Team Leader Regulatory Affairs, adds, “The MDR is supposed to strengthen innovation, but it actually makes it more difficult.” Not only have the effort and costs for registration increased enormously - the time-to-approval has also become much longer.
Advantages of MDR for WEINMANN
Despite the challenges, Ratschiller sees opportunities in the MDR: “I believe that the MDR gives us a good opportunity to boost our international business. By fulfilling the new requirements for the European region, we have already met the majority of international ones as well.”
André Schulte agrees: “We can already see the opportunities emerging for us now as small ventilation manufacturers withdraw from the market. We are well positioned for the future to obtain national and international approvals efficiently.” The MDR helps WEINMANN stand out from the competition by meeting high quality standards and establishing itself as a trustworthy manufacturer on the global market.
MDR Success Drivers
Andrés Ramos-Jimenez, Regulatory Affairs Manager, an expert in technical documentation at WEINMANN, was involved in MDR implementation right from the start: “I am glad we were able to turn the MDR requirements and restrictions into a positive transformation process. The MDR was a wake-up call that is helping us improve while ensuring the survival of the company. Once we've managed to do that as a medium-sized company, we can be proud of ourselves.” Pre-MDR, Andrés's area was not integrated into the development phase. In the meantime, this has changed significantly. “We are no longer the party poopers delaying project completion. In the past, a lack of understanding of our tasks often led to conflicts. Since then, R & D increasingly sees us as a help in the development process rather than a hindrance. We work together proactively.”
Outlook for the Future
Despite the numerous uncertainties and challenges posed by the MDR, WEINMANN’s outlook for the future remains positive. The new requirements have already led to process optimizations and strengthened collaboration within the teams. These trends give occasion for optimism that WEINMANN will not only overcome the current hurdles, but will also remain successful and innovative moving forward. “We are confident about the future and have the opportunity to further expand our market share worldwide, by focusing on our core competence of developing emergency and transport ventilators. To this end, we are reviewing processes and further expanding our relationship with the licensing authorities,” concludes André Schulte.
