Notified Body Management

The Human Products Authorisation and Registration Department is responsible for the ongoing monitoring of Notified Bodies for conformity assessment in Ireland. Regular meetings and communications are undertaken to discuss and resolve issues raised by device manufacturers, Competent Authorities in other Member States or other appropriate parties. Regular surveillance audits and observed audits are conducted by the Compliance Department of the IMB.

Organisations wishing to apply for designation as Notified Bodies by the IMB can contact the medical devices section for further information at medicaldevices@imb.ie.

The Irish Medicines Board - www.imb.ie

Notified Body Management