MDR: 40th Notified Body on NANDO!

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

Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body notified under the Regulation (EU) 2017/745 on medical devices – MDR.

Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

Esentepe Mahallesi Milangaz Caddesi No:75 A/92 Kartal/İstanbul

Istanbul Türkiye

Body Number: 2764

Email: info@notice.com.tr

The Notification covers the following:

General non-active, non-implantable medical devices

  • MD 0101 – Non-active devices for anaesthesia, emergency and intensive care
  • MD 0102 – Non-active devices for injection, infusion, transfusion and dialysis
  • MD 0104 – Non-active medical devices with measuring function
  • MD 0105 – Non-active ophthalmologic devices
  • MD 0108 – Non-active medical devices for disinfecting, cleaning, rinsing

Non-active implants

  • MD 0201 – Non-active cardiovascular implants
  • MD 0202 – Non-active orthopaedic implants
  • MD 0203 – Non-active functional implants
  • MD 0204 – Non-active soft tissue implants

Devices for wound care

  • MD 0301 – Bandages and wound dressings
  • MD 0302 – Suture material and clamps
  • MD 0303 – Other medical devices for wound car

Non-active dental devices and accessories

  • MD 0401 – Non-active dental equipment and instruments
  • MD 0402 – Dental materials
  • MD 0403 – Dental implants

General active medical devices

  • MD 1101 – Devices for extra-corporal circulation, infusion and haemopheresis
  • MD 1102 – Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
  • MD 1104 – Active surgical devices
  • MD 1111 – Software

Monitoring devices

  • MD 1301 – Monitoring devices of non-vital physiological parameters
  • MD 1302 – Monitoring devices of vital physiological parameters

Devices for radiation therapy and thermo therapy

  • MD 1402 – Devices utilising non-ionizing radiation

Horizontal technical competence

  • MDS 7001 – Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
  • MDS 7004 – Medical devices referencing the Directive 2006/42/EC on machinery
  • MDS 7006 – Medical devices in sterile condition
    • Limitations including aseptic, processing, ethylene oxide gas, sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
  • MDS 7009 – Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
  • MDS 7010 – Medical devices incorporating software/utilising software/controlled by software

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


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