the European Commission published a significant proposal in January 2024 (and later adopted in June 2024 as Regulation (EU) 2024/1860) to amend the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), focusing on extending transition periods, streamlining Eudamed database use, and adding new notification requirements for device supply interruptions to prevent shortages and reduce regulatory burdens while maintaining high safety.
Key Changes in the Amendment:
- Extended Transitional Periods: Provided more time for manufacturers to comply with MDR/IVDR, especially for older devices, easing bottlenecks and preventing shortages.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
- Eudamed Roll-out: Mandated a gradual, staggered introduction of the European Database on Medical Devices (Eudamed) for better information sharing.
- Supply Interruption Notification: Introduced a new requirement (Article 10a in MDR/IVDR) for manufacturers to notify authorities and healthcare institutions about ceasing supply of critical devices to avoid public health risks.
- Address Implementation Challenges: Aimed to simplify complex rules, reduce costs, and solve issues like certification bottlenecks that arose since the original regulations took effect.
Timeline & Status:
- Proposal: Published by the Commission in January 2024.
- Adoption: Formally adopted by the European Parliament and Council in June 2024.
- Entry into Force: The adopted Regulation (EU) 2024/1860 entered into force, with related guidance published later in 2024.
This amendment seeks to balance improved patient safety with practical realities, ensuring a stable supply of vital medical products in the EU market.
Get Expert MDR and IVDR Compliance Support
How Operon Strategist Supports Manufacturers
Operon Strategist helps medical device and IVD manufacturers navigate these MDR and IVDR amendments with clear, step by step guidance. From transition planning and Eudamed readiness to impact assessment of the new Article 10a supply notification requirement, the team supports companies in staying compliant without disrupting market access. With hands-on regulatory expertise across the EU, Operon Strategist ensures manufacturers adapt smoothly to regulatory changes while protecting timelines, certifications, and business continuity.
