Agfa Radiology Solutions has achieved EU Medical Device Regulation (MDR) certification for its entire direct radiography portfolio. The company completed the transition of all its direct radiography x-ray rooms, mobiles, and retrofits to comply with the MDR. Agfa was an early adopter and obtained Quality Management System certification according to the MDR for its direct radiography 400 room in 2022. The MDR aims to ensure patients have access to safer and more technologically advanced medical devices by introducing stricter requirements for manufacturers, importers, and distributors.
The challenges faced by medical device manufacturers in maintaining EU MDR compliance are discussed in an article by Hilde Viroux, Maggie Chan, and Dona O’Neil on Med Device Online. The article offers a cost-effective approach to address these challenges. The current economic climate, characterized by a slowdown, inflation, and geopolitical tensions, adds to the complexity of compliance. EU MDR requires manufacturers to regularly update the reports that support the technical documentation of their products. The EU Commission has created transparency and control mechanisms to determine compliance, including the EU database on medical devices (EUDAMED) and the requirement for PSUR submission to notified bodies. Noncompliance can have financial and reputational impacts.
To balance compliance against cost, manufacturers should implement a robust approach to mitigate the risks of noncompliance. This includes mapping out current processes, conducting risk assessments, implementing controls, and monitoring key performance indicators. The article suggests cost reduction opportunities such as product portfolio optimization, process efficiencies, alternative resourcing models, and the use of technology and AI. Maintaining an up-to-date schedule for generating reports and ensuring consistency between functions involved in compliance are crucial. Solid process design, the right technology, and a robust quality management system aligned with a cost-reducing strategy are essential.
The article emphasizes that MDR compliance is not free and companies need to find a way to come to terms with the cost. It also highlights the need for a mindset shift that EU MDR is a team sport and explores potential operational models to strike a balance between cost and compliance. [6945985d] [1b6295d2]