IVDR: 5th Notified Body on NANDO!

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
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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