Article 10a – What Changes for Medical Device Manufacturers?

As of 10 January 2025, a new obligation introduced by Regulation (EU) 2024/1860, under the MDR/IVDR requires manufacturers to notify relevant parties in advance when an interruption or discontinuation of supply is reasonably foreseeable and could result in serious harm or a risk of serious harm to patients or public health in one or more Member States – this is the very basic summary of Article 10a!

This applies to both legacy and MDR-compliant devices, with custom-made devices being excluded.

So, what is required by Article 10a?

If a manufacturer anticipates a disruption or discontinuation in a device supply that could risk patient safety or public health, they must:

• Notify the competent authority of the Member State where the manufacturer or its authorised representative is established.
• Inform the economic operators, health institutions, and healthcare professionals to whom they directly supply the device.

This notification must be made at least six months in advance (exceptions apply) and must include the reasons for the anticipated interruption or discontinuation.

After receiving this information, the competent authority must promptly inform the competent authorities in other EU countries, and the EU Commission.

Economic operators are also required to pass on the notification to their downstream partners, so its important for distributors to also be aware of Article 10a!

To assist with implementation, the European Commission has released:

• MDCG 2024-16  – the official Manufacturer Information Form.
• Q&A on the Obligation to Inform of Device Interruption or Discontinuation –  has further clarification on when and how to notify.

But there are still some practical challenges remain, especially in identifying what constitutes a “reasonably foreseeable” disruption.

What manufacturers should do now

If you haven’t already, now is the time to:

• Review your products to identify devices where a supply disruption could have serious consequences.
• Develop or update internal procedures to ensure Article 10a compliance.
• Establish clear communication lines with economic operators and healthcare providers.

Article 10a introduces yet another regulatory burden for manufacturers—but with a fit-to-need compliance strategy, it becomes manageable. If your team needs support to meet these new requirements, All4Compliance is here to help!