The NANDO database has a new Notified Body under the IVDR!
National Standards Authority of Ireland (NSAI) is the 10th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.
National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Country : Ireland
Phone : +353.1.807.38.00
Fax : +353.1.807.39.25
Email : info@nsai.ie
Website : www.nsai.ie
Notified Body number : 0050
Here below, a short extract what the Notification covers:
Devices intended to be used for blood grouping:
- IVR 0101 Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]
- IVR 0102 Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
- IVR 0103 Devices intended to determine markers of the Kell system [Kel1 (K)]
- IVR 0104 Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]
- IVR 0105 Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]
- IVR 0106 Other devices intended to be used for blood grouping
Devices intended to be used for markers of cancer and non-malignant tumours:
- IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
Devices intended to be used to determine markers of infections/immune status:
- IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents
- Code scope limited to: devices using molecular and immunoassay technologies.
- IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration
- Code scope limited to: Blood, Blood Components
- IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
- IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging
- IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
- Code scope limited to exclude the growth and isolation of viruses
- IVR 0506 Other devices intended to be used to determine markers of infections/immune status
Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures:
- IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
- Code scope limited to: Medicinal Products, Biological Components
Also, the following limitations should be taken into account:
- IVS 1005 Devices in sterile condition: Aseptic processing, Ethylene oxide gas sterilisation (EOG), Moist heat sterilisation, Radiation sterilisation (gamma, x-ray, electron beam), Sterilisation with liquid chemical sterilising agents
- IVP 3004 In vitro diagnostic devices which require knowledge regarding chromosomal analysis: Code scope limited to: Chromosomal staining, FISH in combination with microscopy.
- IVP 3010 In vitro diagnostic devices which require knowledge regarding microscopy: Code scope limited to: Light Microscopy, Fluorescent Microscopy, Electron Microscopy, Stereo Microscopy
- IVP 3011 In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS): Code scope limited to: Molecular Biological testing, Nucleic Acid Assays
- IVD 4006 In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics: Code scope limited to exclude HLA tissue typing
You can find the full scope of its designation on the following link.
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