Interruptions or discontinuations of medical device or IVD supply

This webpage provides information about the requirement for manufacturers to inform specific entities about an anticipated interruption or discontinuation of supply of a medical device or IVD. It also explains what importers and distributors need to do after being informed of an anticipated interruption or discontinuation of supply.

What is the interruption or discontinuation of supply notification requirement?

Regulation (EU) 2024/1860 was adopted in July 2024 and amends the MDR and IVDR.

Article 10(a) of this Regulation introduces a requirement for manufacturers to inform specific entities of an anticipated interruption or discontinuation of device supply to the EU market. 

This applies to certain devices that could result in serious harm or a risk of serious harm to patients or public health.

The entities to be informed include:

• Importers, distributors, health institutions, healthcare professionals and other economic operators to whom a manufacturer has directly supplied a device. 
• The Competent Authority of the member state where the manufacturer or its authorised representative is based.

Article 10(a) applies to all devices, including legacy devices, for which a supply interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States. However, Article 10(a) does not apply to custom made devices. 

It is the responsibility of manufacturers to determine if an anticipated interruption or discontinuation to their device(s) may lead to such harm.

What should device importers and distributors do if notified of an anticipated interruption or discontinuation of a device?

If you are a distributor or importer and are notified of an anticipated interruption or discontinuation of supply, you must inform any entity to whom you have directly supplied that device of the disruption without undue delay. 

When informing other entities of an anticipated interruption or discontinuation, you should use the communication that you have received from the manufacturer. This communication should not be altered or changed in any way, but if required it can be complemented with a communication from you.

Prompt communication of the information  to other entities in the downstream supply of a device is very important as it will help facilitate the implementation of timely appropriate mitigating actions.