Reporting Obligations for Medical Device Manufacturers

This blog was originally posted on 13th November, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY FERNANDA PARO, REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Regulation (EU) 2024/1860 Article 10a – Overview

Medical device manufacturers aiming to sell products in the European market should take note of Article 10a compliance requirements introduced in July through Regulation (EU) 2024/1860. Regulation (EU) 2024/1860, which amends Regulation (EU) 2017/746 and Regulation (EU) 2017/745, introduced Article 10a, a provision designed to secure device availability and prevent potential healthcare disruptions.

Regulation (EU) 2024/1860 brought several notable changes, including updated transitional timelines for In Vitro Diagnostic (IVD) manufacturers, and also had an impact on EUDAMED (European Database on Medical Devices) to make certain procedures faster. However, the introduction of Article 10a stands out due to its impact on both medical device and IVD manufacturers.

Article 10a establishes a mandatory reporting requirement to ensure a consistent supply of critical medical devices and IVDs within the EU. Specifically, manufacturers must now proactively inform relevant Competent Authorities (CA) and health institutions of any anticipated interruption or discontinuation in the supply of certain devices. The goal is to allow healthcare systems to mitigate potential disruptions and maintain continuity of care.

Q&A Document

In October 2024 the European Commission published a Q&A document titled “The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices” to clarify these new obligations. It addresses questions such as when and what to report, who to notify, and when these obligations will take effect.

Article 10a Compliance Requirements

Article 3 of Regulation (EU) 2024/1860 states that Article 10a will enter into force on 10 January 2025. This reporting obligation is separate from regular vigilance and post-market surveillance (PMS) reporting. The responsibility lies primarily with the manufacturer (whether based within or outside the EU) who must inform economic operators (EO) and healthcare institutions directly receiving the affected devices. These informed EOs then must pass this information down the supply chain to other stakeholders.

Manufacturers must assess the potential for significant harm to determine whether to report a supply interruption. This requirement has sparked discussion, as healthcare professionals may rely on specific devices due to training or expertise with them compared to alternatives. Manufacturers may not always be aware of such dependencies. The Q&A document offers examples of risk indicators to help guide reporting, such as whether the device is life-saving, serves vulnerable patient groups, or holds a significant market share.

Reporting is required at least 6 months before the anticipated supply interruption or discontinuation. The Q&A also covers terms like “anticipated interruption or discontinuation” and different categories of causative factors, along with explanations based on definitions of MDCG 2023-3.

Next Steps

Further updates are still expected even though the Q&A document provides substantial guidance. Manufacturers and stakeholders should stay informed on forthcoming guidance to ensure full compliance with Article 10a as these requirements take effect.

References

1. Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance)
2. Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices

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