Marian Harkin
Question:607. Deputy Marian Harkin asked the Minister for Health who the notified body is for medical devices in Ireland; and if he will make a statement on the matter. [2612/24]
View answerTuesday, 23 January 2024
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Written answers
Notified Bodies (NB’s) assess the conformity of products to applicable requirements before manufacturers place them on the EU market.
For some high-risk devices, NBs assess their conformity to the requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
If a device conforms to applicable requirements, a NB issues a CE certificate to the manufacturer. This allows the manufacturer to place their product on the EU market.
NBs can be identified on a device label with a unique 4-digit number.
Manufacturers can apply to any suitable EU NB. The full list of notified bodies based in Ireland and the associated Directives/Regulations may be found on the European Commission website.
The Health Products Regulatory Authority (HPRA) are responsible for NBs under the MDR and IVDR in Ireland.
After designation, they monitor and reassess NBs to ensure they continue to comply with requirements. This reassessment is similar to the designation process.
The National Standards Authority of Ireland (NSAI) has been approved for designation to the new Medical Device Regulations (MDR) 2017/745. The NSAI were the 11th notified body in the world to be designated to the new medical device regulation. Since February 2023, NSAI has also achieved designation under the in vitro Diagnostic Regulation 2017/746. For more information please visit their website here, NSAI - NSAI | National Standards Authority of Ireland