The NANDO database has a new Notified Body under the IVDR!
3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.
3EC International a.s.
Hranicna 18
82105 BRATISLAVA
Country: Slovakia
Phone: +421 2 58318343
Fax: +421 2 58318345
Email: info@3ec.sk
Website: www.3ec.sk
Notified Body number : 2265
Here below, a short extract what the Notification covers:
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: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours: Annex IX(I), Annex IX(II), Annex XI.
Devices intended to be used for human genetic testing:
- IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0403 Other devices intended to be used for human genetic testing: Annex IX(I), Annex IX(II), Annex XI.
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: Annex IX(I), Annex IX(II), Annex XI.
- 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: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents: Annex IX(I), Annex IX(II), Annex XI.
- 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: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0506 Other devices intended to be used to determine markers of infections/immune status: Annex IX(I), Annex IX(II), Annex XI.
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: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0604 Other devices intended to be used for a specific disease: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0606 Devices intended to be used for non-infectious disease staging: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures: Annex IX(I), Annex IX(II), Annex XI.
Devices which are controls without a quantitative or qualitative assigned value:
- IVR 0701 Devices which are controls without a quantitative assigned value: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0702 Devices which are controls without a qualitative assigned value: Annex IX(I), Annex IX(II), Annex XI.
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: Annex IX(I), Annex IX(II), Annex XI.
- 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: Annex IX(I), Annex IX(II), Annex XI.
- IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746: Annex IX(I), Annex IX(II), Annex XI.
You can find the full scope of its designation on the following link.
Days until IVDR is fully applicable: 21 days
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