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Ireland’s NSAI Becomes 11th Notified Body Under EU MDR

February 24, 2020

The European Commission has designated the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. The NSAI is the first Irish notified body to be designated.

The Irish notified body is listed on the commission’s NANDA database for conformity assessments including active implantable devices, active non-implantable devices for imaging, monitoring and/or diagnosis, and non-active non-implantable devices, among others.

NSAI said it will begin accepting applications for conformity assessment activities from April 1, 2020.

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