The medical device regulations require all medical devices to carry the CE marking unless they are within the definitions of custom-made devices or devices intended for clinical investigation. With regard to in-vitro diagnostic medical devices, Directive 98/79/EC requires that all IVD's on the market are CE marked.
The Irish Medicines Board is responsible for the maintenance of a register for class I medical devices, custom-made devices, systems and procedure packs and all in-vitro diagnostic medical devices.
Medical Devices Registration Extranet Login
If you would like to know more information about registration please contact the Human Products Authorisation and Registration Department at email@example.com.