Ireland’s NSAI Designated as 11th Notified Body Under MDR

Regulatory NewsRegulatory News | 13 February 2020 |  By 

The National Standards Authority of Ireland (NSAI) was added to the European Commission’s NANDO database as the 11th notified body and first from Ireland to be designated under the EU’s Medical Devices Regulation (MDR), which takes effect on 26 May.

The designation for the Dublin-based authority is for active implantable devices, active non-implantable devices, non-active implants and long term surgically invasive devices and non-active non-implantable devices, among others. NSAI is also designated under 90/385/EEC Active implantable medical devices, 93/42/EEC medical devices and 98/79/EC In vitro diagnostic medical devices.

Questions remain over whether there will be enough notified body capacity to meet the needs of the medical device industry in the EU, but European commissioner for health Stella Kyriakides said in December, “I want you to know the designation process has been sped up and 12 designations have been completed and we hope that by the first quarter of 2020, we will get up to 20 designations.”

But some other notified bodies expect to be designated after May.



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