IVDR implementation curbs innovation and shifts new product launches away from the EU
A quantitative survey of medical device manufacturers evaluated the real-world impact of the EU Medical Device Regulation and In Vitro Diagnostic Regulation following their initial implementation. Investigators found that the regulatory framework has increased operational costs, prompted portfolio rationalization, and discouraged manufacturers from seeking initial EU approval for new diagnostics. Despite recent amending regulations aimed at easing the burden, the study concludes that the European market is no longer the preferred launch destination for novel diagnostic products. These findings highlight ongoing supply and innovation challenges for European laboratories and diagnostics companies navigating the IVDR transition.
The original study
An impact assessment of the European medical device regulations implementation - the current status quo.
- Authors
- McDermott O, Folan M, Stafylas P
- Journal
- Expert review of medical devices
- Type
- Journal Article
- PMID
- 42507354
Original abstract
BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: 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 rationalized 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. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.