Skip to Content

Manufacturing facilities

What is a manufacturing facility?

A manufacturing facility is a place where an entity, which does not place devices on the market under its own name or under its own trademark, manufactures a device, manufactures one or more critical components of a device to a set of specifications, conducts packaging activities or labelling activities in relation to a device. 

How do I register as a manufacturing facility?

Manufacturing facilities established in Ireland must register their organisation details and device types nationally with us using our online registration form