The National Standards Authority of Ireland (NSAI) has announced its decision to divest its medical-device department to an established testing, inspection and certification (TIC) organisation. The announcement has raised important questions for manufacturers holding CE certificates issued by Notified Body 0050 (NSAI), as well as companies holding NSAI ISO 13485 or Medical Device Single Audit Program (MDSAP) certification.
At this stage, however, manufacturers should distinguish between the decision to divest and an actual transfer or cessation of conformity assessment activities. The announcement does not, in itself, invalidate existing NB 0050 certificates. Furthermore, no completed sale has been publicly disclosed, and manufacturers should not assume that they need to immediately transfer their certificates solely because of the announcement or because they have received offers from other conformity assessment organisations.
What Has NSAI Announced?
NSAI’s Director of Medical Devices, Claire Dyson, announced in August 2026 that NSAI had decided to divest its medical-device department to an established testing, inspection and certification organisation. The prospective acquiring organisation has not been publicly identified.
The communication indicates that, in the short term, there should be very little operational change for manufacturers. NSAI has stated that its services will continue as normal and that there is currently no impact on clients, work in progress, or certificates maintained by NSAI.
In the longer term, NSAI intends to combine its medical-device expertise and capabilities with another established organisation as part of the divestment.
NSAI has also indicated that correspondence relating to the announcement and related client tools should continue to be managed through its designated medical-device communication channels.
