National Standards Authority of Ireland (NSAI) was awarded Notified Body (NB) status under the new EU Medical Device Regulation (MDR).
The new regulation consists of stringent requirements around devices, clinical data and post-market surveillance.
As part of its role as a NB, the NSAI is now able to inspect medical devices and other products for safety and compliance.
Having a NB within Ireland means that multinationals and local businesses will be able to have their devices checked in Ireland.
Currently there are only eleven other NBs. This is thought to be because all NBs require approval by European officials. A delay by the European Commission has meant there are much fewer NBs at this stage than anticipated. For example, the NSAI applied in November 2017 (over two years ago).
A shortage of NBs could result in a large number of devices not being re-certified in time, and therefore possible shortages.