The European Commission has announced a new notified body designation under the EU’s Medical Devices Regulation (MDR): the National Standards Authority of Ireland. NSAI is the 11th notified body to be designated under the MDR, which will take effect on 26 May, 2020.
The designation for NSAI is for:
- 90/385/EEC Active implantable medical devices
- 93/42/EEC Medical devices
- 98/79/EC In vitro diagnostic medical devices
- Regulation (EU) No 305/2011 – Construction products
- Regulation (EU) 2017/745 on medical devices
- 2014/31/EU Non-automatic weighing instruments
- 2014/32/EU Measuring Instruments Directive
To view the full list of Notified Bodies, visit NANDO.
