Presentation (CTI)

OBJECTIVES: The increase in product costs due to the transition from the Medical Device Directive (MDD) to the Medical Devices Regulation (MDR) in the European Union is a significant challenge for many manufacturers of medical devices. The objective of this research is to conduct a cost-mapping assessment of the MDR framework for manufacturers, to highlight the overall financial burden and evaluate the specific costs associated with the transition.
METHODS: A combination of descriptive and exploratory approaches was adopted. Initially, a comprehensive literature review was conducted to gain a detailed overview on the process steps for the MDR transition. To enhance the research quality, an interview with regulatory experts was conducted. The interview provided deeper insights and highlighted different cost areas not well covered in existing literature, while providing real-world data demonstrating the impact on the experts’ daily work.
RESULTS: The research identified various costs associated with the transition to MDR. Although some cost elements existed under MDD, MDR introduced additional and more complex requirements. These include more enhanced audits, additional clinical evidence generation, more resource-intensive preparation and maintenance of technical documentation, stricter classification rules, and greater involvement of Notified Bodies. Further burdens from the MDR may include additional staff training, supply chain disruptions, and market delays. Switching to MDR is estimated to cost manufacturers about 3.5% to 5% of their total revenue in Europe.
CONCLUSIONS: The MDR sets higher standards that improve patient safety and the quality of medical devices in the EU. While the transition process has increased the cost and complexity of bringing products to market, the significant benefits to patient health and the resulting improvements in safety and regulatory oversight outweigh these financial challenges. However, these financial challenges strengthen the case for price (re)negotiations by manufacturers to individual EU member states.