On October 21, 2024, the major groups of the European Parliament published a joint resolution, urging the newly elected EU Commission to take immediate action to address existing challenges in implementing Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR), with the aim of ensuring safe patient care.
The key demands of the resolution include:
- Adoption of pending delegated acts: The Commission is asked to publish critical legal acts by the end of the first quarter of 2025.
- Improved regulations for rarely used (orphan) and pediatric products: Access to these products should be enhanced through easier access to existing clinical data in national registries.
- Faster approval processes for innovative products: Introduction of “fast-track” options to bring new technologies to market more quickly.
- Exemptions in re-certification: Simplified procedures for product modifications to avoid unnecessary re-certifications.
- Monitoring of availability: Continuous monitoring and ensuring the supply of essential products in the EU market.
The resolution aims to improve access to medical devices and reduce regulatory hurdles while maintaining patient safety.
