MDR: 29 Notified Bodies on NANDO

The NANDO database newly listed 29 Notified Bodies under the MDR!

TUV NORD Polska Sp. z o.o has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

TUV NORD Polska Sp. z o.o
ul. Mickiewicza 29
40-085 Katowice
Country : Poland

Phone : +48 32 7864646
Fax : +48 32 7864601

Email :
Website :

Notified Body number: 2274

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

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

  •  MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
    • Excluding MRI
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
    • Excluding products used in ophthalmology
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
    • Including only infusion pumps, devices for dialysis, anaesthesia machines and devices for administration or removal of substances
  • MDA 0307 Active non-implantable respiratory devices
    • Excluding hyperbaric chambers
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
    • Excluding active prostheses
  • MDN 1102 Non-active osteo- and orthopaedic implants
    • Excluding bone graft substitute for orthopaedic indications, knee, shoulder and hip joint replacement, hyaluronic acid implant for intra-articular use, bone cement
  • MDN 1104 Non-active soft tissue and other implants
    • Including only urological tapes, surgical meshes ligament and tendon prostheses made of multifilament polyester fibers
  • MDN 1204 Non-active non-implantable devices for wound and skin care
    • Excluding sutures
  • MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
    • Excluding devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
    • Including only ultrasound gels, medication cups
  • MDS 1005 Devices in sterile condition
    • Including: aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation, filtration
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
    • Limited to devices emitting electromagnetic radiation for use on the human body according to Annex XVI p. 5
  • MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
    • Excluding processing of glass
  • MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
    • Excluding processing of leather
  • MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
    • Excluding processing of animal materials
  • MDT 2012 Devices which require installation, refurbishment
    • Limited to electronic devices and medical gas installations

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.

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