New Publication: Assessing the Impact of the EU Medical Device Regulations
HealThink is proud that our Scientific Director, Panos Stafylas, has contributed to a new publication, "An impact assessment of the European Medical Device Regulations implementation – the current status quo," developed as part of the EU4MEDTECH project (European Framework for Advanced Medical Technology Evaluation and Follow-up), which has been accepted for publication in the Expert Review of Medical Devices journal.
The paper assesses the current impact of the medical device and in vitro diagnostic device regulations (MDR/IVDR) on the device industry in the EU through the lens of post-implementation and the amending regulation, and in advance of the final transition to the IVDR/MDR. The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalised their existing product portfolios and removed devices from the market, as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff.
This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that, despite regulatory amendments and other EU interventions to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.
Congratulations to Dr Olivia McDermott of the University of Galway for her excellent leadership on this initiative.
Many thanks to the Greek Patients Association for the opportunity to work on this interesting project and to Martha Folan, and, of course, all our partners in the EU4MEDTECH project for a great collaboration. We hope these findings help inform future EU policy discussions.
This research was funded by the EU Horizon Research program -EU4MEDTECH project under grant agreement [101191683]. More info about EU4MEDTECH project here.
The paper assesses the current impact of the medical device and in vitro diagnostic device regulations (MDR/IVDR) on the device industry in the EU through the lens of post-implementation and the amending regulation, and in advance of the final transition to the IVDR/MDR. The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalised their existing product portfolios and removed devices from the market, as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff.
This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that, despite regulatory amendments and other EU interventions to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.
Congratulations to Dr Olivia McDermott of the University of Galway for her excellent leadership on this initiative.
Many thanks to the Greek Patients Association for the opportunity to work on this interesting project and to Martha Folan, and, of course, all our partners in the EU4MEDTECH project for a great collaboration. We hope these findings help inform future EU policy discussions.
This research was funded by the EU Horizon Research program -EU4MEDTECH project under grant agreement [101191683]. More info about EU4MEDTECH project here.