IVDR: 12th Notified Body on NANDO!

 

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

Sertio Oyis the 12th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

Sertio Oy

Biokatu 10

Tampere

Finland

Body Number: 3018

info@sertio.fi

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;
• 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;
• …

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;
• ….

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
• …

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 1005 Devices in sterile condition
  • Aseptic processing, Ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray electron beam)
• …
• 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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