IVDR: 11th Notified Body on NANDO!

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

Eurofins Electric & Electronics Finland Oy is the 11th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.

Eurofins Electric & Electronics Finland Oy

PL 47 Kivimiehentie 4

FI-02150 Espoo

Country: Finland

Phone: +358406311311

Fax: +358406311311

Email: FirstnameSurname@eurofins.fi

Website: https://www.eurofins.fi/expertservices

Notified Body number: 0537

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

Devices intended to be used for human genetic testing

• IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders;
  • Excluding epigenetics and large-scale human exome analyses
• IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis;
  • Excluding epigenetics and large-scale human exome analyses
• IVR 0403 Other devices intended to be used for human genetic testing;
  • Excluding epigenetics and large-scale human exome analyses

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

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

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