On July 9, 2024, Regulation (EU) 2024/1860 introduced amendments to the EU Medical Devices Regulations (MDR and IVDR). Among the changes, the newly added Article 10a requires manufacturers to notify supply interruptions or discontinuations of certain medical devices and in vitro diagnostic devices (IVDs). Article 10a strengthens patient safety and continuity of care. By requiring early communication, it minimizes risks related to device unavailability.
The European Commission has also released a Q&A document to clarify its practical application.
Scope of article 10a
The notification obligation provided for in article 10a applies when:
- The manufacturer anticipates that the supply of a medical device or IVD will be discontinued, or interrupted, and
- It is reasonably foreseeable that such interruption or discontinuation could result in serious harm or risk to patients or public health
This ensures timely action and communication to mitigate potential negative impacts on patients.
Article 10a also applies to legacy devices, as per Article 120(13) of the MDR and Article 110(11) of the IVDR.
Notification process
Once the manufacturer foresees a (potentially) harmful interruption or discontinuation of his device to occur, he must inform:
- The Competent Authority of the Member State where it or its authorised representative is located, as well as
- The economic operators, healthcare institutions, and professionals to whom it directly supplies the device.
This notification to CA and Eos must be performed at least six months before the interruption/discontinuation and must detail the reasons of the foreseen disruption (such as regulatory, manufacturing, or supply chain issues).
The notified economic operators, in their turn, must further relay the communication to the downstream supply chain.
Exemptions from Notification
Manufacturers are not required to notify interruptions and/or discontinuations if:
- A similar successor device is available to meet demand,
- Sufficient stock by their side exists to cover the gap,
- No significant risk of harm is confirmed by healthcare institutions or professionals due to alternatives,
- The discontinuation or interruption concerns a custom-made device.
Practical Considerations for Manufacturers
To comply with Article 10a, manufacturers should, among others:
- Evaluate Risk: Assess potential harm linked to the supply disruption, considering the device’s purpose and availability of alternatives.
- Plan Notifications: Submit information using the European Commission’s ‘Manufacturer Information Form’ and update it as needed.
- Maintain Traceability: Ensure compliance with Article 25 MDR/IVDR by keeping accurate supply chain records.
When does it start applying?
The provisions of Article 10a of the MDR/IVDR will take effect on 10 January 2025. Manufacturers are not required to report anticipated supply interruptions or discontinuations of a device before this date, even if the actual interruption or discontinuation occurs after 10 January 2025.
However, manufacturers are encouraged by the Commission to voluntarily notify supply interruptions or discontinuations prior to 10 January 2025, following existing best practices.
How Obelis can assist?
Obelis, as your European Authorised Representative, can help navigate Article 10a compliance, ensuring timely notifications and communication with the authorities. Contact us today to safeguard together patient safety!
Obelis can act as your Responsible Person and Authorised Representative for MDR and IVDR.
References:
EUR-Lex (2024). 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. Retrieved 16/12/2024.
European Commission (2024). The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices – Questions and Answers. Retrieved 16/12/2024.
Georgios Mariolos
Regulatory Intelligence & Innovation Department
20.12.2024
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