Glossary for N
National Competent Authority reports
Method of communication between national Competent Authorities on medical device vigilance issues.
An application for a marketing authorisation made directly to the IMB. This procedure can only be used to apply for a marketing authorisation for the Irish market. The authorisation cannot be used in any other Member State.
An organisation that has been accredited (or approved) by a Member State to assess the compliance of medical device with EU standards.