The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
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The Health Products Regulatory Authority (HPRA), an Irish agency in the sphere of healthcare products, has published a guidance document dedicated to notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices. The guidance structured as a questions-and-answers document describes the relevant regulatory requirements, and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could be also subject to changes, should such changes be reasonably needed to reflect corresponding amendments to the underlying legislation. In particular, the guidance document provides a comprehensive overview for health institutions in Ireland that manufacture and use in-house medical devices (MDs) and in vitro diagnostic medical devices (IVDs).
It explains the requirement to notify the Health Products Regulatory Authority about their activities and offers detailed instructions on the notification process, including the information required and relevant regulations. Additional resources for health institutions involved in in-house IVDs are available on the HPRA website.
Who is this Notification Process for?
According to the guidance, this notification process is designed specifically for health institutions in Ireland that produce and utilize in-house MDs and IVDs. The term “health institution” is defined under Regulation (EU) 2017/746 (IVDR), Article 2(29), as any organization primarily focused on patient care, treatment, or the promotion of public health.
Why is Notification Required?
Health institutions involved in manufacturing and using in-house MDs and IVDs are legally obligated under national law to notify the HPRA.
This requirement is established by:
- S.I. No. 691/2021 – Medical Devices (Registration) Regulations.
- S.I. No. 365/2022 – In Vitro Diagnostic Medical Devices (Registration) Regulations 2022.
These institutions must provide relevant information to the HPRA upon request to ensure compliance with regulations.
How to Submit a Notification?
Notifications are submitted via the HPRA’s online in-house manufacture notification form, available on the HPRA in-house IVD webpage. All mandatory fields must be completed before submission.
Required Information for Notification
As explained by the authority, to complete the notification, the following details must be provided:
- Health Institution Details: Name, address, telephone number, and a general email address.
- Public Declaration URL (if applicable): If publicly available, provide the URL for the institution’s declaration (see section 5).
- Contact Information: Details of an authorized contact person.
- Type of Notification: Confirmation of notification for in-house MDs or IVDs.
- Acceptance of Terms: Acknowledgment of terms and conditions outlined in sections 11 and 12.
Public Declaration Requirements
Institutions must comply with public declaration requirements as outlined in Article 5(5e) of the Medical Device Regulation (MDR) and Article 5(5f) of the IVDR. The HPRA may request this information if it is unavailable at the time of notification.
Separate Notifications for MDs and IVDs
A single notification can cover both in-house MDs and IVDs, but institutions also have the option to submit separate notifications for each category.
Notification for Laboratories
Individual laboratories within a health institution do not need to notify the HPRA separately. Coordination between laboratories is essential to ensure proper notification by a designated authority within the institution.
Designated Authority for Notification
The notification must be submitted by an individual authorized to act on behalf of the health institution.
This person should:
- Serve as the main contact point for the HPRA.
- Coordinate with relevant departments, such as laboratories producing in-house IVDs.
- Ensure internal governance structures are informed about the notification process.
Updating Contact Details
If the contact details of the designated individual change, the HPRA must be notified via email, quoting the original notification case reference number.
Adding Additional Contact Points
Institutions can request additional contact points by emailing the HPRA. The correspondence should specify the role and scope of responsibilities for each additional contact, ensuring their number is kept to a minimum.
Terms and Conditions
As per Article 5(5) of the MDR and IVDR, the HPRA reserves the right to:
- Restrict the manufacture and use of specific in-house devices.
- Conduct inspections, including document reviews and physical or laboratory checks.
- Verify compliance with applicable regulations.
By submitting the notification, the health institution confirms its commitment to adhere to these regulations and to notify the HPRA of any significant changes to submitted information or contact details.
Submission Timeline
Health institutions should submit notifications promptly upon identifying that they are manufacturing and using in-house MDs or IVDs.
Post-Submission Process
Once a notification is submitted, the HPRA will issue a case reference number via email, confirming receipt of the submission.
Notification Cost
There is no cost associated with submitting a notification to the HPRA.
Conclusion
In summary, the notification process outlined by the HPRA is a critical regulatory requirement for health institutions manufacturing and utilizing in-house MDs and IVDs. This guide clarifies the responsibilities of these institutions, ensuring compliance with national and EU regulations while promoting transparency and public health.
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