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The Health Products Regulatory Authority (HPRA) requires health institutions that manufacture and use in-house medical devices (MDs) and in vitro diagnostic medical devices (IVDs) to notify them of their activities. 

 

This notification process ensures that the health institution complies with national and EU regulations, specifically:

1. Who Needs to Notify? Health institutions, defined as organisations primarily focused on patient care, treatment, or public health promotion, must notify the HPRA if they manufacture or use in-house MDs or IVDs. This includes hospitals, clinics, or research facilities that produce these devices solely for internal use.
2. Why is Notification Required? Under Irish national law (S.I. No. 691/2021 for MDs and S.I. No. 365/2022 for IVDs), health institutions are required to identify themselves to the HPRA. This helps ensure that any in-house devices meet the necessary safety, quality, and performance standards under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The HPRA may request detailed information about the devices, and institutions must be able to provide this upon request.
3. Key Information Required for Notification:
   • Health institution details: Name, address, and contact information.
   • Public declaration: A public declaration that the health institution complies with the relevant EU regulations for in-house MDs and IVDs. If not available, this may be requested at a later stage.
   • Contact person: A designated individual within the health institution who will serve as the primary contact for regulatory communication.
   • Device types: Information on whether the notification is for MDs, IVDs, or both.
   • Terms acceptance: Confirmation that the health institution accepts the terms and conditions outlined by the HPRA and is aware of its legal obligations.
4. Public Declaration Requirement: Health institutions must publish a public declaration on their website stating their compliance with the regulations governing in-house manufactured MDs and IVDs. This declaration is required under Article 5(5e) of the MDR and Article 5(5f) of the IVDR.
5. Notification Process: The notification is completed by submitting the in-house manufacture notification form, available on the HPRA website. All mandatory fields must be filled in, and the health institution must provide any requested information about the in-house MDs or IVDs it manufactures.
6. Additional Key Points:
   • Laboratory Coordination: Laboratories within a health institution do not need separate notifications. A single notification should cover all relevant departments or laboratories.
   • Notification Updates: Institutions are responsible for updating the HPRA if there are changes to the contact details or other significant information related to the devices.
7. Inspections and Compliance Checks: The HPRA reserves the right to inspect the health institution’s activities, request documentation, and perform physical or laboratory checks to ensure compliance with the regulations. If compliance issues are found, the HPRA may also restrict the manufacture or use of any specific type of in-house device.

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Why is this important?

By complying with the HPRA’s notification process, health institutions can ensure that their in-house medical devices and IVDs meet regulatory standards, promoting patient safety and device effectiveness. It also demonstrates transparency and a commitment to regulatory oversight, which is essential for maintaining high standards in healthcare.

 

Failure to notify or comply with the HPRA requirements can lead to restrictions or legal consequences, affecting the institution's ability to use its in-house manufactured devices.

 

For more information or to get started with our services, contact us at mdd@mddltd.com or submit a webform - https://med-di-dia.com/contact.php. Let us be your partner in regulatory compliance and ensure your institution's in-house medical devices are fully compliant with HPRA requirements.

 

 

 

 

 

 

 

 

 

 

 

 

 

For more insight into the requirements for health institutions who manufacture and use in-house IVDs in Ireland please also review our online webinar.