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IT driven QMS-tool for MDR compliance of early-stage medical device development

Delft University of Technology (TU Delft)

Delft University of Technology (TUD), is a leading technical university located in The Netherlands, contributing to solving global challenges by educating socially responsible engineers, expanding the frontiers of the engineering sciences. TUD has a strong focus on research and education in the field of health technology, specialised in health technology, including Bioelectronics, Biomechanical Engineering, Imaging Physics, regenerative medicine, and medical robotics, including Master of Science programs in BioMedical Engineering and Technical Medicine. TUD collaborates with various research institutes, hospitals, and companies to develop innovative solutions to health-related problems e.g. the Medical Delta, a collaboration between TUD, Leiden University Medical Centre, and Erasmus MC and Convergence for Health & Technology, between Erasmus MC, EUR and TUD to cross-pollinate between ideas, procedures, instruments and products for which MDR requirements require alignment with legal obligations. This application supports one aspect of this: A MDR-tool for compliance and a dedicated Quality Management System (QMS).

According to the European Commission, 500,000 medical devices are available on the European market and about 10,000 new medical devices are added every year. In Europe, an average of 1% of GDP is spent on healthcare. Annual per capita expenditure on medical technologies in Europe is about €225 (average according to MedTech Europe) these numbers warrant a proactive approach to secure this part of the EU market.

The MDR is a European Union (EU) regulation becoming applicable on 31 December 2027 for higher risk devices and on 31 December 2028 for medium and lower risk devices. To comply with the MDR, medical device designers and engineers are to provide extensive documentation, quality control evidence, prior to clinical evidence demonstrating the safety and efficacy of their product as part of these requirements. These requirements are time-consuming, costly. Hence, dedicated information, guidance, documentation and an electronical QMS are required to streamline and control this process, ensuring legal compliance to foster medical innovation technology transfer and uptake. With Universities it starts with awareness of and assessing requirements of adherence to MDR-regulation.

Firstly, to date a simple electronic tool to assess the need for compliance is not available and medical innovation projects are not properly judged and correctly prepared for the MDR-regulation. Secondly, the lack of experience with preparing for MDR-regulation is clear, as at universities new students may enter this field each semester, requiring continual support and training. Instruments developed within research institutes lack strong guidance and ease of use. An increasing number of health-related innovations mature into early clinical feasibility investigations, and standard research files are submitted for approval from METC (Medisch Ethische Toetsing Commissie). These investigational studies focus on clinical applicability of the medical device and should be conducted according to the Good Clinical Research Practice standard (GPRS) as defined in ISO 14155. Currently there is ample experience within research institutes what exactly should be communicated to the METC to obtain approval to test the innovation. By implementing a dedicated electronic MDR-regulation solution assures compliance to prevent obstacles at a later stage. Especially for research organisations the MDR-regulation has a significant impact, as this is where the idea, design and prototypes are being made and where the whole journey starts. MDR compliance is essential for medical products to make a chance for exploitation, commercialisation and market entry as all critical aspects regarding regulation, safety, and patient needs.


Applications closed on the 24th of January 2024 at 17:00 CET.