MDR: 33 Notified Bodies on NANDO

The NANDO database newly listed 33 Notified Bodies under the MDR!

ul. Puławska 469
02-844 Warszawa
Country : Poland

Phone : +48 22 464 52 01
Fax : +48 22 647 12 22

Email :
Website :

Notified Body number
: 1434

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

Below, an extract from NANDO, where conditions/limitations are listed:

  • MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
    • Excluding active non-implantable devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) 
  • MDS 1005 Devices in sterile condition
    • Including aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), sterilisation with liquid chemical sterilising agents
  • MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
    • Excluding materials of human origin

Under the designation scope without limitations:

  • MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • MDA 0301 Active non-implantable devices utilising ionizing radiation
  • MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDA 0311 Active non-implantable dental devices
  • MDA 0312 Other active non-implantable surgical devices
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • MDN 1104 Non-active soft tissue and other implants
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDN 1207 Non-active non-implantable diagnostic devices
  • MDN 1209 Non-active non-implantable dental materials
  • MDS 1001 Devices incorporating medicinal substances
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • MDS 1013 Class III custom-made implantable devices

Have a look at the Analysis of NB Designation prepared by our partners AKRA TEAM. You will find it in our dedicated Library of Documents – Notified Body: MDR and IVDR.

Do not forget to follow our dedicated LinkedIn page for all the updates!

Leave a Reply

Your email address will not be published.