MDR: 33 Notified Bodies on NANDO

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

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
ul. Puławska 469
02-844 Warszawa
Country : Poland

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

Email : pcbc@pcbc.gov.pl
Website : www.pcbc.gov.pl

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
• …
• …

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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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