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Notified Body Update

  • Posted by: inetika
  • Category: GLOBAL NEWS

TuV SUD Denmark becomes the 45th Notified Body to be designated under the MDR, and is the first from Denmark. This compares with there now being 12 Notified Bodies designated under the IVDR.

The announcement for TuV SUD Denmark follows a few weeks after a second Swedish Notified Body was designated under the MDR, this being RISE Medical Notified Body (RISE MNB), a company that was not previosuly designated under the MDD. Based in Kista, RISE has been designated for around forty product codes in the non-invasive device field.

A third Notified Body has also been designated in the past few months, this being the Czech Institute For Testing And Certification (ITC) which was designated under the MDR.

Update 23 April 2024: AFNOR Certification, France, the certification arm of the national stadards body, has also now been designated as a Notified Body for the MDR, covering non-implantable devices.

The full list of designations under the MDR can be found here, and the IVDR list can be accessed here.