On-Line Services

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 by 7th December 2003.

The Human Products Authorisation and Registration Department of the IMB is responsible for the maintenance of a register for class 1 medical devices, custom-made devices, systems and procedure packs and all in-vitro diagnostics medical devices. To assist with the registration of devices an electronic option is provided.

If you wish to register a device online please use the following link to Registration.

Alternatively you may use the registration applications forms available from our publications section.

The Irish Medicines Board - www.imb.ie

On-Line Services