Quality Management Systems and Article 10a: Ensuring Compliance

How Can Quality Teams Ensure Article 10a Compliance with Quality Management Systems?

As of January 10, 2025, the implementation date for Article 10a under the EU MDR and IVDR has arrived, and manufacturers must prioritize updating their quality management systems (QMS) to ensure compliance.

A robust QMS is not just a regulatory requirement—it’s the foundation for managing the risks associated with supply interruptions or discontinuations. Here’s how Article 10a impacts QMS and what steps manufacturers should take.

[Download the Complete Guide to Article 10a Compliance and Mastery]

Why QMS Matters for Article 10a

Article 10a introduces new obligations for manufacturers to notify stakeholders about potential device shortages or discontinuations that could impact patient care. These obligations require a systematic approach to monitoring, evaluating, and reporting supply chain risks—all of which must be integrated into the QMS.

A compliant QMS ensures:

• Early identification of supply risks.
• Consistent and accurate communication across the supply chain.
• Documentation that demonstrates adherence to Article 10a requirements.

Key QMS Updates for Article 10a Compliance

• Risk Monitoring and Evaluation
  Manufacturers must incorporate mechanisms to detect risks related to supply chain interruptions, regulatory challenges, or manufacturing constraints. This includes:

  • Setting triggers for identifying foreseeable disruptions.

  • Conducting regular supply chain risk assessments.

  • Collaborating with suppliers to anticipate and mitigate potential issues.

• Evaluation of Systems and Processes
  Notified bodies will check if the manufacturer’s QMS can:
  • Monitor triggers and assess supply risks.
  • Ensure the documentation and justification of the decision to notify – or not notify – authorities about potential disruptions.
• Documentation and Records
  Maintaining detailed records is critical for demonstrating compliance. Manufacturers should:

  • Archive notifications, risk assessments, and stakeholder communications.

  • Use templates and tools to ensure consistency and completeness.

  • Notified bodies will check if manufacturers can demonstrate compliance with Article 10a and the manner in which the requirements have been implemented into their QMS.

    
    
    This includes:
    • The adoption of tools like the MDCG 2024-16 Manufacturer Information Form.
    • The review of any documented decisions to notify or not notify authorities about potential disruptions or interruptions. 

• Training and Resource Allocation
  Compliance depends on staff understanding their roles in implementing Article 10a. Manufacturers must update training programs to include:

  • Identification of risks requiring notification.

  • Proper use of QMS tools and documentation.

  • Coordination with internal and external stakeholders.

Article 10a Challenges and Solutions

• Smaller Manufacturers: Limited resources may make it difficult to implement the necessary updates. Prioritizing high-risk areas and leveraging external expertise can help.

• Complex Supply Chains: Managing multiple suppliers and stakeholders requires clear documentation and efficient tracking systems to ensure timely action.

Final Steps for Manufacturers

Aligning your QMS for Article 10a involves more than minor adjustments—it requires strategic planning and organization-wide commitment. Start by:

• Conducting a gap analysis of your current QMS.
• Engaging with supply chain partners to ensure alignment.
• Auditing your system regularly to confirm readiness for compliance checks by notified bodies.

With Article 10a compliance, a well-prepared QMS will not only meet regulatory requirements but also enhance operational resilience and patient safety. Don’t wait—integrate these updates now to ensure compliance.