IVDR: 17th Notified Body on NANDO!

Since the 1st of May 2025, the NANDO database has a new Notified Body under the IVDR!

DNV Product Assurance from Norway is the 17th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

DNV Product Assurance AS

Veritasveien 1 1363 Høvik

Norway

+47 67578800

medical@dnv.com

www.dnv.com

Body number: 2460

 

The Notification covers the following:

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 tissue typing

• IVR 0201 Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration
• IVR 0202 Other devices intended to be used for tissue typing

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
• IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours

Devices intended to be used for human genetic testing

• IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
• IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
• IVR 0403 Other devices intended to be used for human genetic testing

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
• 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
• 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
• 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 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
• IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
• IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
• IVR 0604 Other devices intended to be used for a specific disease
• IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
• IVR 0606 Devices intended to be used for non-infectious disease staging
• IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
• IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
• IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures

Devices which are controls without a quantitative or qualitative assigned value

• IVR 0701 Devices which are controls without a quantitative assigned value
• IVR 0702 Devices which are controls without a qualitative assigned value

Class A devices in sterile condition

• IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
• IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
• IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

 

Horizontal technical competence

• IVD 4001 In vitro diagnostic devices which require knowledge regarding bacteriology
• …
• IVD 4009 In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics
• IVD 4010 In vitro diagnostic devices which require knowledge regarding mycology
• IVD 4011 In vitro diagnostic devices which require knowledge regarding parasitology
• IVD 4012 In vitro diagnostic devices which require knowledge regarding virology
• IVP 3001 In vitro diagnostic devices which require knowledge regarding agglutination tests
• …
• IVP 3014 In vitro diagnostic devices which require knowledge regarding tests of cell function
• IVS 1001 Devices intended to be used for near-patient testing
• IVS 1002 Devices intended to be used for self-testing
• IVS 1003 Devices intended to be used as companion diagnostics
• IVS 1004 Devices manufactured utilising tissues or cells of human origin, or their derivatives
• IVS 1005 Devices in sterile condition
  • Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam).
• IVS 1006 Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)
• IVS 1007 Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)
• IVS 1008 Instruments, equipment, systems or apparatus
• IVS 1009 Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measure
• IVS 1010 Devices incorporating software/utilising software/controlled by software
• IVT 2001 In vitro diagnostic devices manufactured using metal processing
• …
• IVT 2011 In vitro diagnostic devices which require packaging, including labelling

You can find the full scope of its designation on the following link.

DNV Product Assurance AS has been previously notified under the Regulation (EU) 2017/745 – MDR as well.

Are you looking for a notified body for your medical devices and IVDs? Contact us!

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