The European Commission has updated its Q&A on the information obligations related to the interruption or discontinuation of supply of certain medical devices and in vitro diagnostic devices (IVDs).
By way of background, Regulation (EU) 2024/1860—adopted in 2024—introduced several amendments aimed at strengthening patient safety and improving regulatory efficiency. Key developments include the gradual roll-out of EUDAMED and the introduction of Article 10a.
Article 10a establishes a legal obligation for manufacturers to notify authorities of any interruption or discontinuation in the supply of certain devices.
Why Article 10a Matters?
Timely notification of supply disruptions helps safeguard continuity of care by allowing healthcare providers and authorities to anticipate shortages and take appropriate measures. Early communication reduces the risk of device unavailability and supports better planning and mitigation strategies across the healthcare system.
The updates to the Q&A document can be seen below;
- In Question 9.2, the following note has been revised from ‘This question may be further complemented by a decision tree diagram’ to: ‘Note: This question is complemented by a decision tree diagram.’
- Footnote 10 has been updated and includes a link to the location of the decision tree diagram.
The updated Q&A document can be accessed using the following link
