New EU regulation impacts medical devices and in vitro diagnostics

On 9 July, the European Union has introduced regulation (EU) 2024/1860, aimed at ensuring the continuous availability and safety of medical devices and in vitro diagnostics (IVDs) within the Union.

This regulation imposes new obligations on manufacturers and distributors to enhance supply chain resilience and address patient safety risks. Key elements include mandatory notifications for supply interruptions, a phased implementation of the European database on medical devices (Eudamed), and revised deadlines for so-called legacy devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). What are the specifics of these changes and their implications for stakeholders?

Enhanced notification requirements for supply chain disruptions

Effective from 10 January 2025, regulation (EU) 2024/1860 mandates that manufacturers must notify stakeholders of any planned discontinuation or interruption in the supply of medical devices and IVDs at least six months in advance, that is, before the anticipated interruption or discontinuation.

This notification must include a comprehensive risk assessment addressing potential patient harm in one or more Member States. Specifically, manufacturers need to inform relevant national competent authorities, economic operators, and, if necessary, healthcare professionals and patients. The new regulation specifies that these notifications should detail the reasons for the supply disruption and include measures being taken to mitigate any adverse effects on patient care.

Competent authorities will be required to disseminate this information to their counterparts in other Member States and to the European Commission, ensuring a coordinated response across the Union. This aims to pre-emptively address supply chain vulnerabilities and prevent critical shortages that could jeopardise patient health.

Manufacturers and distributors are encouraged to promptly review and potentially revise their distribution agreements and Quality Management Systems (QMS) to comply with these new obligations. This preparation includes ensuring that notification clauses in agreements do not unintentionally trigger claims of anticipatory breach.

Gradual roll-out of Eudamed

The new legislation outlines a phased implementation of Eudamed. This approach allows for individual modules to be rolled out as they become ready, rather than waiting for the entire system to be completed.

Initially, the Actor Registration module and the UDI/Devices registration module are to be prioritised. However, the exact timelines remain fluid, with some Member States already recognising the voluntary modules officially, emphasising the importance of early engagement with the system.

The regulation aims to fully integrate Eudamed by 2026, ensuring comprehensive traceability and transparency across the medical device lifecycle.

Economic operators should not delay in familiarising themselves with Eudamed functionalities to ensure readiness upon full deployment. Early adoption of Eudamed modules can streamline compliance processes and reduce administrative burdens by providing a centralised platform for data submission and regulatory reporting.

Adjusted deadlines for IVDR legacy devices

Similar to the March 2023 adjustments under the Medical Devices Regulation (MDR), the IVDR now features staggered deadlines for the submission of technical documentation and QMS updates for legacy IVDR devices. These adjustments are coupled with specific obligations, such as having lodged a formal application with a notified body and having signed a written agreement with the notified body by the regulation's set deadlines.

Subject to compliance with the new regulatory conditions, placing on the market or putting into service of legacy IVDs may be extended up to December 2027, 2028 and 2029. However, the IVDR's approach necessitates careful planning to meet these segmented dates.

Further, the regulation sets out that higher-risk class devices must comply earlier than lower-risk class devices, ensuring a prioritised approach to maintaining patient safety.

While these adjustments offer more time for compliance, the Commission's evaluation in 2025 is expected to address any remaining challenges with MDR and IVDR implementation. This evaluation could lead to further refinements based on stakeholder feedback and practical experiences post-implementation.

The regulation also introduces measures to facilitate the extension of certification for devices still under assessment, ensuring market continuity and preventing device shortages.

Osborne Clarke comment

The EU's new regulation presents significant operational and compliance challenges for the medical devices and diagnostics sector.

The mandatory six-month advance notification for supply disruptions necessitates thorough planning and risk assessment, ensuring that patient safety remains uncompromised. Manufacturers should act promptly to review and update their distribution agreements and QMS to align with these requirements, avoiding potential legal pitfalls.

The phased roll-out of Eudamed represents a critical step towards greater transparency and traceability. Economic operators (including importers) are advised to engage with the system early, leveraging the phased implementation to streamline compliance and reporting processes. Proactive preparation for the Eudamed integration will be essential to avoid disruptions once the system is fully operational.

For IVDR legacy devices, the staggered deadlines require meticulous planning and prioritisation. Manufacturers should stay vigilant, ensuring timely submission of technical documentation and QMS updates to meet these deadlines. The forthcoming EU evaluation in 2025 is hoping to address ongoing MDR and IVDR challenges, potentially introducing further regulatory adjustments.