Q&A: Webinar Questions and Expert Answers about Article 10a

Q+A: How Does Article 10a Impact Manufacturers, Legacy Devices, and Supply Chain Management?

1. Is Article 10a applicable to legacy devices that are not transitioning to MDR?

According to Erik Vollebregt, Article 10a applies to all devices on the market under the MDR/IVDR, including legacy devices, even if they are not transitioning to MDR. This is because the regulation aims to address supply interruptions that could pose serious risks to patients or public health. However, if a legacy device is no longer marketed due to the expiration of its MDD certificate, Article 10a may not apply since the device would already be considered unavailable.

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2. What is considered a “serious harm” under Article 10a?

Serious harm refers to situations where the unavailability of a device leads to significant health consequences, such as the inability to provide necessary treatments, life-threatening conditions, or serious deterioration in health. Examples include life-sustaining devices or those used for vulnerable populations. The MDCG 2024-16 form provides further guidance on identifying such risks.

3. Do manufacturers need to notify stakeholders about interruptions if alternative devices are available?

Erik Vollebregt emphasized that manufacturers must assess whether alternatives can adequately meet market demand. If a manufacturer controls a significant market share, even the presence of alternatives may not fully mitigate the risk of serious harm. Manufacturers should document their rationale, supported by post-market surveillance data and market intelligence.

4. Should manufacturers maintain a list of devices exempt from Article 10a reporting?

According to Erik Vollebregt, maintaining documentation to justify that certain devices do not meet the criteria for Article 10a reporting is a good practice. This should include evidence demonstrating that supply interruptions would not pose serious harm.

5. How should manufacturers handle “exceptional circumstances” such as sudden supply chain disruptions?

Exceptional circumstances, like natural disasters or sudden supplier failures, allow manufacturers to notify stakeholders without adhering to the six-month notice period. In such cases, communication must occur “without undue delay.” Manufacturers should still document these events and their responses as part of their QMS.

6. What is the role of notified bodies in assessing compliance with Article 10a?

Notified bodies will check whether manufacturers have systems in place to comply with Article 10a during audits. This includes reviewing QMS updates, training records, and procedures for identifying and reporting supply risks. However, they are not expected to verify every individual notification.

7. What information should be included in notifications to economic operators and competent authorities?

Notifications must align with the MDCG 2024-16 form, which specifies categories such as device identification, type of disruption, and justification for potential harm. However, information shared with economic operators should be carefully reviewed to avoid disclosing sensitive data.

8. Does Article 10a require manufacturers to stockpile devices?

While Article 10a encourages risk management strategies like maintaining bridging stock, it does not mandate stockpiling. Manufacturers should document their supply chain strategies and consider them as part of their risk assessments.

9. What are the practical challenges for smaller manufacturers in complying with Article 10a?

Smaller manufacturers may struggle with resource constraints, limited supply chain visibility, and insufficient documentation processes. Erik Vollebregt recommended prioritizing high-risk devices, leveraging external expertise, and updating economic operator agreements to align with Article 10a requirements.

10. Are manufacturers responsible for informing healthcare institutions directly?

Manufacturers must ensure their communication chain includes all relevant stakeholders, including healthcare institutions. This can be done directly or through economic operators, but manufacturers remain responsible for the accuracy and completeness of the information.

Watch the webinar replay, read the transcript, and download the slides here>>