IVDR: 13th Notified Body on NANDO!

The NANDO database has a new Notified Body under the IVDR!

Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

 

The Notification covers the following:

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 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;

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;

Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures

• IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease;
• IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components;
• 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;

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 4002 In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry
• …
• IVS 1001 Devices intended to be used for near-patient testing
• …
• IVS 1005 Devices in sterile condition
  • Limited to: – aseptic treatment – Ethylene oxide gas sterilization (EOG) – Wet heat sterilisation – radiation sterilisation (gamma rays and electron beam)
• IVS 1006 Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)
• …
• IVS 1010 Devices incorporating software/utilising software/controlled by software
• …
• IVT 2011 In vitro diagnostic devices which require packaging, including labelling

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

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