Legacy Device Manufacturers and Article 10a: A Practical Guide

What Must Legacy Device Manufacturers Do to Meet Article 10a Requirements, Effective January 10, 2025?

With the clock ticking past January 10, 2025, legacy device manufacturers face new obligations under Article 10a of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Compliance is not optional, and understanding these requirements is critical to avoiding regulatory pitfalls.

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What is Article 10a?

Article 10a was designed to address supply interruptions or discontinuations of medical devices that could jeopardize public health. It requires manufacturers to report foreseeable issues to competent authorities and other stakeholders in a timely manner.

Key scenarios include:

1. Temporary supply interruptions - suggested as those exceeding 60 days - pose a serious risk to patients.
2. Permanent discontinuation of a device, where alternatives may not adequately meet demand, while also posing a serious risk to patients.
3. Legacy devices, already on the market, are fully within the scope of this regulation, again while posing a serious risk to patients.

Manufacturer Responsibilities:

1. Monitoring and Reporting
   Manufacturers must implement robust systems to identify and evaluate risks in their supply chain. When issues are identified, they are required to notify the competent authority in their country—or the country of their authorized representative if outside the EU. This must be done six months in advance for foreseeable disruptions.

2. Accurate Documentation
   Notifications must be formalized using the MDCG 2024-16 Manufacturer Information Form, which standardizes the details manufacturers need to share about the device and the risks posed by its unavailability.

3. Stakeholder Communication
   The information must cascade down to importers, distributors, and healthcare institutions without modification. Stakeholders rely on these details to mitigate the effects of shortages.

Challenges for Manufacturers

Resource constraints pose a challenge, especially for smaller manufacturers. Forecasting disruptions can be complex, particularly when dependent on external suppliers or critical components. Over-reporting, however, risks creating market rumors that can harm a manufacturer’s competitive position.

Preparing for Compliance

Manufacturers should:

• Update Quality Systems: Integrate Article 10a requirements into QMS and train relevant personnel.
• Enhance Collaboration: Build strong relationships with suppliers and distributors to anticipate issues early.
• Plan for Audits: Notified bodies will evaluate compliance, making documented processes and justifications essential.

By addressing these steps now, legacy device manufacturers can ensure compliance with Article 10a, safeguarding both their market presence and public health.