Interruption or discontinuation of the supply of medical devices
Manufacturers’ reporting of interruption or discontinuation of the supply of medical devices
From 10 January 2025, the MDR obliges manufacturers of medical devices to report to the competent authority in Denmark anticipated interruption or discontinuation of the supply of certain medical devices if such interruption or discontinuation could result in a risk of harm to patients or public health in Denmark.
The obligation implies that manufacturers, in the case of anticipated interruptions of the supply of certain medical devices, must inform the competent authority of the Member State where the manufacturer or their authorised representative is established. In Denmark, the report must be made to the Danish Medicines Agency.
This is the form to be used for the report:
Please send the form to the Medical Devices Department of the Danish Medicines Agency.
The European Commission has prepared a Q&A covering practical aspects related to the implementation of Article 10a:
Q&A - Regulation (EU) 2024/1860 Article 10a MDR and IVDR
Further information is available on the Commission's website: