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 the Eudamed actor registration module 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. 

In all other scenarios, manufacturers of custom-made devices must register their organisation and device details with the HPRA using our online registration form.