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