Interruptions or discontinuations of medical device or IVD supply
This webpage is for device industry.
It 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.
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:
- 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.
How can manufacturers inform the HPRA of a supply disruption?
If you are an Irish-based manufacturer, or, if you are a third country-based manufacturer and have an Irish-based authorised representative, you must notify the HPRA of any an anticipated interruption or discontinuation which could result in serious harm or a risk of serious harm to patients or public health in one or more Member States that may impact the European market.
The European Commission has published a Q&A document covering the practical aspects of complying with Article 10(a). This Q&A clarifies who manufacturers should notify, when they should notify and how they can notify.
It also explains key considerations about how you can approach your assessment to determine if a supply disruption may result in serious harm to patients or public health.
We would encourage you to carefully review and follow the instructions and guidance provided within this document.
To notify us of an anticipated interruption or discontinuation , please complete a Manufacturer Information Form and submit it to us using our online contact form. Please select 'medical devices' as the category and 'regulatory query' as the topic.
You must also notify your downstream supply chain actors and health institutions of these anticipated interruption or discontinuation could, directly.
If you have any questions about the notification process, please submit them using our online contact form.
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 could a device, you must inform any entity to whom you have directly supplied that device of the disruption without undue delay.
When informing other entities of a 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.