Medical device and IVD supply disruptions
This webpage is for device industry, healthcare institutions and healthcare professionals.
It provides an overview of the key considerations relating to device supply disruptions.
What is the shortage notification requirement?
Regulation (EU) 2024/1860, is an amendment to the EU Medical Device Regulations, and was adopted in July 2024. 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 a supply disruption to their device(s) may lead to such harm.
HPRA and HSE webinar on medical device shortages
Together with our colleagues in the HSE, we hosted a webinar on medical device shortages. This webinar provides a practical overview of how the shortage notification requirement under the MDR and IVDR is applied in practice.
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 supply disruptions that 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 a supply disruption, please complete a supply disruption notification form linked below and submit it to devices@hpra.ie. You must also notify your downstream supply chain actors and health institutions of these supply disruptions, directly.
If you have any questions about the notification process, please email devices@hpra.ie.
What should device importers and distributors do if notified of a device supply disruption?
If you are a distributor or importer and are notified of a device supply disruption, 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 supply disruption, 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.
What should health institutions and healthcare professionals do if notified of a device supply disruption
If you work in a health institution, or are a healthcare professional and you receive a notification of a device supply disruption, please take the following steps:
- Ensure the notification is brought to the attention of relevant staff.
- Investigate if mitigating actions can be taken to overcome the issue, such as redistributing stock or sourcing an alternative product.
Health institutions and healthcare professionals that operate within the HSE should be aware that the HSE has established a process for Irish based HSE hospitals and healthcare professionals to follow where they have been notified of a device shortage.
This process involves completing and submitting a supply shortage template to the HSE by email. From there, the HSE’s supply disruption and shortage steering group will review your submission and consider appropriate mitigating actions. For additional information about these actions the process of informing the HSE of a notified supply disruption, please visit their webpage.