EU MDR and IVDR Regulation Revision
The European Parliament has adopted a resolution emphasizing the “Urgent need to revise the medical devices regulation (MDR/IVDR).” This move addresses the growing challenges faced by the medical device industry, with a focus on balancing innovation with patient safety.
Learn More About GSPR Requirements for EU MDR and IVDR
Looking For a Medical Device Regulatory Consultant?
Key Highlights of the Resolution:
- Reducing administrative burdens without compromising patient safety.
- Introducing support measures for small and medium-sized enterprises (SMEs), making it easier for them to comply with regulations.
- Eliminating unnecessary re-certification of products already compliant, reducing delays and costs.
- Transparency in notified bodies’ fees and fee structures, calling for clear, predictable costs.
- Fast-tracking approval for innovative technologies to meet evolving medical needs.
- Support for small markets, specifically orphan and paediatric devices, to ensure they are not neglected under the regulations.
- Inclusion of e-health applications within the MDR framework, expanding the scope to cover digital health innovations.
- Urgent full implementation of EUDAMED, the European database on medical devices, which is seen as crucial for improving the regulatory system.
The European Commission is expected to propose actionable solutions by Q1 2025, signaling potential regulatory changes on the horizon that could significantly impact the industry.
How Operon Strategist Can Help with MDR and IVDR Revisions
As the EU calls for urgent revisions to the MDR and IVDR, Operon Strategist is here to assist medical device companies in adapting to these changes. Our regulatory experts provide guidance to ensure compliance while streamlining processes to reduce administrative burdens. We offer tailored support for SMEs and help fast-track approvals for innovative technologies. Additionally, we aid in integrating e-health applications within the MDR framework and navigating EUDAMED effectively. Contact us today to learn more about how we can support your regulatory needs and help you deliver innovative solutions for patient care.
