Reporting on interruption or discontinuation of supply under Article 10a of the MDR and the IVDR Regulations
As of 10 January 2025, the obligation introduced by Regulation (EU) 2024/1860 is in force. This Regulation inserts Article 10(a) into Regulation (EU) 2017/745 and into Regulation (EU) 2017/746, establishing a notification obligation in the event of interruption or discontinuation of supply of medical devices and in vitro-diagnostic medical devices.
Obligations of manufacturers
Manufacturers of medical devices must notify competent authorities and stakeholders in the event of interruption or discontinuation of supply, except for custom-made devices. If the interruption or discontinuation of the supply of a device may cause serious harm to patients or to public health, the manufacturer is obliged to send a specific notification to the competent authority of the Member State in which it is established, as well as to all economic operators, health institutions and healthcare professionals to whom it directly supplies the device.
Obligations of other economic operators
The economic operators who have received information on the anticipated interruption or discontinuation of supply must, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the anticipated interruption or discontinuation.
Deadline for notification
The notification must be sent at least 6 months before the anticipated interruption or discontinuation of supply, except in exceptional circumstances.
Method of reporting to the competent authority
For notification to the competent authority, the information required in the form must be provided by the manufacturer, its authorised representative or any other entity acting on behalf of the manufacturer and must be sent to the following email address: .
Additional information
Detailed guidance provided by the European Commission is available in the form of questions and answers on the official website. For additional information, enquiries may be addressed to JAZMP at
