MDR: 41st Notified Body on NANDO!

The NANDO database has a new Notified Body under the MDR!

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. is the 41st EU Notified Body notified under the Regulation (EU) 2017/745 on medical devices – MDR.

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Mutlukent Mahallesi 2073 Sokak No:10 Umitkoy-CANKAYA

Ankara

Türkiye

udem@udem.com.tr

www.udem.com.tr

Body Number: 2292

The Notification covers the following Horizontal technical competence

• MDS 1001 Devices incorporating medicinal substances
• MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)
• MDS 1005 Devices in sterile condition
  • Limited to aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilization, radiation sterilisation (gamma, x-ray, electron beam), thermic sterilisation with dry heat
• MDS 1006 Reusable surgical instruments
• MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body
• MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices
• MDS 1010 Devices with a measuring function
• MDS 1011 Devices in systems or procedure packs
• MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • Limited to MDR Annex XVI Article 1,2,3 devices
• MDS 1013 Class III custom-made implantable devices
  • Limited to dental and orthopaedic devices
• MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device
• …
• MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
  • Limited to weaving, knitting or plastic materials
• …
• ….
• MDT 2012 Devices which require installation, refurbishment
• MDT 2013 Devices which have undergone reprocessing

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

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