What Notified Bodies Need to Know About Article 10a

What Are the Key Responsibilities and Challenges for Notified Bodies Under Article 10a Compliance?

With the arrival of the January 10, 2025, implementation date for Article 10a under the EU MDR and IVDR, notified bodies (NBs) have new responsibilities in assessing compliance. These bodies act as critical gatekeepers, ensuring manufacturers meet regulatory standards while supporting the overarching goal of safeguarding public health. Here’s what notified bodies need to know.

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Understanding Article 10a

Article 10a mandates manufacturers to notify competent authorities, economic operators, and healthcare institutions about foreseeable interruptions or permanent discontinuations in device supply. These notifications are essential for mitigating risks to patients and public health caused by potential shortages.

Notified bodies will not directly oversee Article 10a reporting but will play a crucial role in assessing whether manufacturers have implemented systems and processes to meet these requirements.

Key Areas of Focus for Notified Bodies

1. Integration into Quality Management Systems (QMS)
   During audits, notified bodies must verify that manufacturers have updated their QMS to reflect Article 10a requirements. This includes:

   • Processes for identifying supply risks.

   • Communication protocols to notify stakeholders.

   • Evidence of training programs for staff.

2. 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.

3. Documentation and Records
   Notified bodies will check if manufacturers can demonstrate compliance with Article 10a and how the requirements have been implemented into the 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.

Challenges for Notified Bodies

• Early Audits: During initial audit cycles, notified bodies may encounter variability in how manufacturers interpret and implement Article 10a. Establishing benchmarks for best practices will take time.

• Resource Allocation: With many manufacturers requiring oversight, NBs must ensure their teams are adequately trained and resourced to assess Article 10a effectively.

• Gray Areas: Exceptional circumstances, such as unforeseen supply chain disruptions, may require nuanced evaluation to determine compliance.

Preparing for January 2025

To address these challenges, notified bodies should:

• Develop Audit Protocols: Establish consistent methodologies for assessing Article 10a compliance across manufacturers.
• Train Auditors: Equip audit teams with a clear understanding of the regulation and its practical implications.
• Engage with Stakeholders: Collaborate with manufacturers and competent authorities to clarify expectations and address ambiguities.

By focusing on these areas, notified bodies can support a seamless transition to Article 10a compliance, contributing to the resilience and reliability of the medical device market.