New Revision of European Medical Device Regulations: Towards Greater Transparency and Safer Access for All
In response to current challenges regarding the accessibility and safety of medical devices, the European Parliament approved a landmark resolution on October 23, 2024, to revise the regulatory framework for these products across the European Union. This urgent update to the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) aims to address critical issues affecting the availability and quality of devices, particularly in high-demand areas and emerging technologies.
Why is this revision necessary?
Since the implementation of the MDR and IVDR, the sector has encountered numerous hurdles, especially for small and medium-sized enterprises. Limited capacity among notified bodies to evaluate products, coupled with administrative complexities, has slowed access to vital devices. While the new regulatory framework was designed to prevent past safety scandals, delays in certification and supply chain challenges have created uncertainty, impacting equitable access to essential devices across the region.
Key updates in the resolution:
Transparency and Accessibility: The Parliament calls for increased transparency in the conformity assessment process conducted by notified bodies, enabling manufacturers to better understand and plan for certification timelines and costs.
Support for small and medium-sized enterprises: Emphasizing the need to reduce administrative burdens for small and medium-sized enterprises, this measure supports innovation in the sector, ensuring safe and swift market access for new devices.
Data Protection in Digital Health: The resolution proposes extending MDR regulations to cover e-health applications, enhancing user data security.
Strengthening “Orphan Device” Categories: Clear definitions and streamlined processes for devices targeting rare and pediatric diseases will support their development without compromising patient safety.
Full Implementation of EUDAMED: The Eudamed database is set to play a pivotal role in improving transparency and access to information for both professionals and the public.
This revision meets the urgent need for a regulatory framework that aligns with the realities of the European medical device market, balancing innovation with safety and accessibility. The proposed changes ensure that EU citizens’ health is prioritized while strengthening the sector’s global competitiveness.
