CE Marking for medical devices
The medical device industry has become an important cornerstone of the Irish economy with over 25,000 workers and exports in excess of €6 billion a year.
Medical devices are rigorously regulated by EU Directives covering health, safety and environmental protection. Medical devices complying with the essential requirements of these Directives are entitled to display the CE Marking, which allows the device to be sold anywhere across the European Union and European Free Trade Area.
NSAI – the Notified Body
The Irish Medicines Board is the Competent Authority in Ireland for the implementation of EU and national legislation relating to medical devices, medicines and blood products.
The Board has in turn approved NSAI as the Notified Body to carry out the conformity assessment procedures to ensure compliance with a number of Medical Directives.
NSAI’s responsibilities
NSAI has extensive responsibilities for the quality of a range of products covered by the following Medical Device Directives (or some of their annexes as specified):
In addition to our responsibility for these Directives, NSAI has specific expertise in providing CE Markings for drug-device combination products.
Online application forms