Manufacturers of custom-made medical devices
What is a manufacturer of a custom-made device?
A manufacturer of custom-made devices is any entity who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark while meeting the following criteria:
- The device is for the sole use of a particular patient exclusively to meet their individual conditions and needs.
- The device is accompanied by a written prescription detailing specific design characteristics.
- The device is not mass-produced.
How do I register as a manufacturer of custom-made medical devices?
Manufacturers of custom-made devices must register their organisation details on Eudamed
where they:
- exclusively place class III implantable custom-made devices on the market. This is to enable notified bodies to issue QMS certificates.
- need to report a serious incident. All manufacturers of custom-made devices must obtain an actor ID before they can report a serious incident using the Eudamed vigilance module.
Where the criteria above is met, organisation details must be registered. To register organisation details, you can login or create an account on the Eudamed landing page.
For more information on how to register organisation details, please see the Eudamed actor registration module.
For more information on how to register device details please see the Eudamed device registration module.
In all other scenarios, manufacturers of custom-made devices must register their organisation and device details with the HPRA using our online registration form
Frequently asked registration questions
How does the HPRA process registration applications?
Eudamed applications
We validate Eudamed registration applications for Irish-based:
- Manufacturers
- Authorised representatives and their non-EU manufacturers
- Importers
- System and procedure pack producers
Once validated, you will receive a single registration number (SRN) from Eudamed. Registrations validated on Eudamed will also be registered nationally.
National registration applications
We validate registration applications for Irish-based:
- Distributors
- Manufacturing facilities
Once validated, you will receive a HPRA registration number.
Eudamed and national registration applications will be processed within 10 working days.
How much does it cost to register?
There is an annual maintenance fee for all registered economic operators. This is based on the registration information provided to us both directly and via EUDAMED so it is important to keep information up to date. Invoices are sent to economic operators in quarter 2 of each year.
An additional administration fee must be paid by any entities that register directly with the HPRA (i.e. not via EUDAMED). This fee must be received before registration is confirmed.
Please refer to section 9 of our fee application form for human products below to see relevant fee codes and payment instructions. Additional resources relating to fees are also provided below.
How do I contact the HPRA?
What is the legal basis for registering with the HPRA?
Registration obligations for economic operators are outlined in Chapter III of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Medical Devices Regulation (IVDR).
National requirements relating to the registration of organisations and health institutions established in Ireland are provided for in: