Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe.

Abstract

Purpose: The new Medical Device Regulations (MDR) in Europe represent unprecedented challenges for researchers in academic environments. Adherence to regulatory frameworks, like the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization. However, the MDR now extends its reach into the preliminary phases of pre-clinical research, imposing new challenges and necessitating compliance for any clinical investigation involving medical device safety or performance.

Methods: We have systematically engineered and implemented a Quality Management System (QMS) tailored to meet the distinct needs of academic institutions. Our objective was to establish a comprehensive framework that enable our research group to comply with MDR without hindering innovation and discovery. Specifically, we engineered a traditional commercial QMS aligned with ISO13485 to fulfill academic needs. We ensured the QMS focused on requirements relevant to pre-market clinical investigations and considered appropriate roles for an academic setting.

Results: We present an optimized QMS implementation to satisfy the urgent need for research institutions to align with the MDR. Notably, our efforts yielded demonstrable results, culminating in the successful approval of research projects by the Swedish Medical Product Agency (MPA). This achievement stands as a testament to the impact of our work within the regulatory landscape.

Conclusion: Here, we share the insights and challenges we encountered during the implementation of an appropriate and efficient QMS for academic research, which we believe can serve as a guiding example for other academic research groups. By presenting our QMS implementation validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal importance of MDR compliance among researchers in Europe. Our contribution seeks to provide a roadmap for fellow research groups in navigating the evolving regulatory landscape while sustaining their focus on groundbreaking research and innovation in the field of biomedical engineering.