Navigating the Impact of EU Regulation 2024/1860 on Medical Device and IVD Manufacturers

Worried about supply chain delays and transition timelines in the medical device industry? You’re not alone: the EU has taken a step forward toward addressing medical device availability. Regulation EU 2024/1860, published in 2024, focuses on critical supply chain issues and extends transition timelines. The regulation amends the existing EU Regulations 2017/745 (MDR) and 2017/746 (IVDR) with several critical updates that manufacturers must navigate to ensure compliance and maintain market access.

What’s driving the new regulation? These issues are at the heart of it:

• Delayed development of EUDAMED
• Supply chain disruptions
• Transitional provisions for IVDs

In this blog post, we will explore the key aspects of EU Regulation 2024/1860 and its impact on manufacturers.

Gradual Rollout of EUDAMED

To understand the regulation, you need to understand the European database on medical devices, otherwise known as EUDAMED. This database is an IT system created to manage information on medical devices by tracking them throughout their life cycle. However, the development of certain electronic systems within EUDAMED has been significantly delayed due to technical complexities. Prior to the launch of new regulation several EUDAMED modules were available for voluntary use, but full, mandatory use was pending the completion and validation of all six modules. Here is where the new regulation comes in. EU Regulation 2024/1860 introduces a phased rollout of modules – a module becomes mandatory six months after its notice is published in the Official Journal of the European Union (OJEU), without waiting for all modules to be completed.

Note that the gradual rollout of EUDAMED will require manufacturers to ensure that their data management systems are compatible with the new database requirements. This includes updating internal processes to capture and report data accurately. Be sure to maintain records of all data submitted to EUDAMED – including device registrations, clinical investigations, and performance studies – so that you can demonstrate compliance with the new regulation.

There are three ways to add your data into EUDAMED:

• User interface (UI): This is the simplest method, requiring only a PC with internet access and a browser. Users can manually enter data directly into EUDAMED through the UI.
• XML bulk upload / download: Users need to upload data in XML format via the UI. This method requires some IT support to handle the complexity of XML data formats and validation rules. Bulk downloads are also in XML format, which may require additional software for readability.
• Machine-to-machine data exchange (M2M-DTX): This automated method involves transmitting data between an external system and EUDAMED. Data must be converted to the XML format specified by EUDAMED and an access point for eDelivery must be set up. This is the most complex and costly option, suitable for large-scale data exchanges and frequent updates.

Key questions:

• Do you have procedures to handle EUDAMED updates?
• Is IT support included in your processes?
• Are your data management systems capable of interfacing with EUDAMED?
• Do you need software upgrades or to implement new data capture protocols?

What Should You Do for Supply Chain Interruptions?

The regulation also addresses supply chain issues to prevent harm to patients if a medical device were to become unavailable. What should you do if your organization anticipates a delay? The EU MDR already mandates that manufacturers notify competent authorities and relevant stakeholders if they foresee an interruption or discontinuation in the supply of a device that could result in serious harm or a risk of serious harm to patients or public health (Article 10a) should the device become unavailable. However, EU Regulation 2024/1860 provides additional clarification and more detailed requirements, including:

• Notifications must be submitted at least six months in advance of the anticipated interruption or discontinuation
• More details should be provided – including who should be informed, such as economic operators, health institutions, and competent authorities – along with an outline of information flow
• Notifications must include a reason for the interruption or discontinuation, such as regulatory issues, manufacturing problems, supply chain disruptions, and other factors (e.g., marketing or business decisions)
• There should be an assessment of whether an interruption or discontinuation may result in serious harm to patients or public health

The updated obligation around communicating potential supply interruptions requires organizations to have robust supply chain monitoring and contingency planning. Manufacturers must develop strategies to communicate effectively with stakeholders and mitigate potential disruptions. Manufacturers should also document all communications with authorities and health institutions regarding supply interruptions or discontinuations to demonstrate compliance with EU Regulation 2024/1860.

Key questions:

• Do you have a robust supply chain management plan that includes identifying alternative suppliers and maintaining adequate inventory levels?
• Do you have communication protocols for potential disruptions, including a clear means for disseminating information?
• Have you established procedures for monitoring supply chains, which may include developing advanced monitoring tools to track supply chain performance?

Transitional Provisions for IVDs

Although the number of notified bodies is increasing, there are still concerns about delays in conformity assessments. In response, the regulation extends transition periods for certain IVDs once again. The extended transition periods for IVDs are:

• Class D devices: Until December 31, 2027
• Class C devices: Until December 31, 2028
• Class B and sterile Class A devices: Until December 31, 2029

For IVD manufacturers, understanding and adhering to the transitional provisions is key. This may involve reevaluating product classifications and ensuring compliance with updated conformity assessment procedures. Manufacturers should maintain conformity assessment reports and be sure to note any changes in product classifications or assessment procedures to demonstrate their compliance with EU Regulation 2024/1860. Your organization may want to enhance its regulatory affairs team to include experts who can navigate the complexities of the new regulation and provide ongoing compliance support.

Action items:

• Reassess your product portfolio to ensure compliance with the updated classifications, and reevaluate product classifications where appropriate
• Update your conformity assessment procedures to align with the transitional stipulations

Training Your Team on the New Requirements

The time to communicate with your team is now. Conduct training sessions for your regulatory and quality assurance teams to familiarize them with the new requirements and ensure they are prepared to implement necessary changes. Be sure to maintain training records on the new regulatory requirements and any internal process updates that you make.

Check out our related training courses:

• EU MDR Training for the European Medical Device Regulation (2017/745)
• EU In Vitro Diagnostic Regulation Training (IVDR 2017/746)
• Medical Device Supplier and Subcontractor Quality Management Training

Conclusion

By proactively addressing these changes, medical device and IVD manufacturers can ensure compliance with EU Regulation 2024/1860 and maintain their market presence in the European Union.

Pro tip: Maintain detailed records of all compliance activities, including data submissions to EUDAMED, supply chain communications, and conformity assessments. This documentation will be crucial during audits and inspections.