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 : biuro@tuv-nord.pl
Website : www.tuv-nord.pl

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

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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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