Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers

The European Commission has just released a Q&A document aimed at clarifying the new requirements introduced by Amendment 2024/1860 to the MDR/IVDR regulation. Effective January 2025, this amendment requires medical device and in vitro diagnostic manufacturers to strengthen transparency and better anticipate supply chain risks. This compliance guide is designed to ensure patient safety and enable greater traceability through the Eudamed database. Here’s a look at the key points to better understand the impact of this amendment on European medical device manufacturers.

1. Amendment 2024/1860 to MDR/IVDR: A Stronger Framework for Safety and Transparency

This new amendment represents a significant advancement in the regulation of medical devices across Europe. Aimed at bolstering safety and preventing supply chain disruptions, it imposes new obligations on manufacturers to better anticipate and manage potential public health risks.

One major development in this amendment is the introduction of Article 10a, which requires manufacturers to notify competent authorities and healthcare institutions at least six months prior to any anticipated interruption or cessation of supply for critical devices. This measure is essential to enable authorities to plan preventive actions, thereby ensuring continued patient care.

In addition, the amendment supports the gradual implementation of the Eudamed database. Eudamed centralizes all relevant information on devices and economic operators, providing enhanced product tracking and greater transparency for healthcare professionals.

2. New Notification Obligation: Anticipating and Preventing Supply Disruptions

Amendment 2024/1860 introduces a notification requirement for manufacturers, obliging them to inform health authorities of any anticipated supply chain risks for critical devices. Starting January 10, 2025, manufacturers must provide a six-month notice for any planned supply disruption or cessation of essential devices. This requirement allows health authorities and healthcare stakeholders to prepare alternative solutions to protect patients.

In exceptional circumstances, such as natural disasters or supply chain interruptions, this notice period may be shortened, provided that authorities are informed as soon as the risk is identified. This obligation encourages manufacturers to adopt a proactive approach and strengthen their risk management practices.

These new rules represent a step forward in improving transparency and safety in the supply chain of medical devices across Europe, while reinforcing manufacturers’ responsibility for preventing potential disruptions to patient care.

3. Eudamed: Transparency and Traceability for European Medical Devices

The Eudamed database is a key tool for enhancing transparency and traceability of medical devices. With this amendment, Eudamed’s rollout is progressing to enable faster and more comprehensive access to critical device information.

Eudamed aims to centralize all data related to medical devices, economic operators, and certificates of compliance, providing authorities, healthcare professionals, and manufacturers with a clear, comprehensive view of product status. In case of compliance issues or supply disruptions, Eudamed becomes an essential resource for prompt and appropriate action.

This gradual deployment represents a major step forward for medical devices in Europe, offering a critical reference framework for all stakeholders and contributing to increased compliance with MDR and IVDR requirements.

4. Direct Impact on Patient Safety and Continuity of Care

Amendment 2024/1860 prioritizes patient safety and continuity of care. By imposing strengthened transparency and notification obligations on manufacturers, it enables health authorities and professionals to better anticipate and manage supply chain risks.

With this six-month notification requirement, healthcare institutions now have more time to put alternative measures in place, which is crucial for critical devices. Designed to respond to unexpected events like natural disasters, this regulatory framework underscores the European Union’s commitment to maintaining a high level of healthcare safety.

These new requirements encourage manufacturers to take a proactive approach and enhance patient protection against sudden care interruptions.

Towards Enhanced Compliance and Safety for Medical Devices in Europe

Amendment 2024/1860 to the MDR/IVDR regulation marks a significant step towards greater safety and transparency in Europe’s medical device sector. With clear notification obligations and the deployment of the Eudamed database, manufacturers now have additional tools to ensure compliance with European standards and meet public health expectations.

For manufacturers, this amendment represents an invitation to adopt stronger risk management practices. With easier access to traceability information for authorities and healthcare professionals, this new legislative framework is an advance in transparency, safety, and supply chain management.

Need Help with Your MDR/IVDR Compliance? Contact Our Experts!

The new MDR/IVDR compliance requirements, though rigorous, offer manufacturers an opportunity to improve their risk management processes and prepare for European Union expectations. At CSDmed, we support you at every step of your compliance journey, from notification of supply disruptions to Eudamed integration.

Get in touch with our team of experts for personalized support and a compliance process audit. Together, let’s ensure compliance that guarantees safety, quality, and long-term presence of your medical devices on the European market.