The NANDO database is richer for a new Notified Body under the IVDR!
DEKRA Certification B.V. is the 5th EU Notified Body notified under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR.
DEKRA Certification B.V.
Meander 1051 / P.O. Box 5185
6825 MJ ARNHEM / 6802 ED ARNHEM
Country : Netherlands
Phone : +31:(0)88 968 3000
Fax : +31:(0)88 968 3100
Email : product.certification@dekra.com
Website : www.dekra-product-safety.com
Notified Body number : 0344
Here below, a short extract what the Notification covers:
- 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 0506 Other devices intended to be used to determine markers of infections/immune status
- 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 0701/IVR 0702 Devices which are controls without a quantitative/qualitative assigned value
- 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 1009 Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures
- …
You can find the full scope of its designation on the following link.
Days until IVDR is fully applicable: 344 days
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