MDR: 50 Notified Bodies on NANDO!

The NANDO database now includes the NEOEMKI LLC, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to 50. Details about the newly designated NB:

NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)

The extract from the Notification, which includes some restrictions to the designation scope:

• 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
  • Restriction: Review of audiological devices only.
• MDA 0302 Active non-implantable devices utilising non-ionizing radiation
• MDA 0305 Active non-implantable devices for stimulation or inhibition
• MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
• MDA 0310 Active non-implantable devices for ear, nose and throat
  • Restriction: Review of hearing aids only.
• MDA 0312 Other active non-implantable surgical devices
  • Restriction: Review of powered surgical drills and saws.
• MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
• MDA 0315 Software
• MDA 0316 Medical gas supply systems and parts thereof
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
• MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
• MDN 1102 Non-active osteo- and orthopaedic implants
• MDN 1103 Non-active dental implants and dental materials
• MDN 1104 Non-active soft tissue and other implants
• MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
• …
• MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
  • Restriction: Review of ultrasound gels only.
• MDS 1001 Devices incorporating medicinal substances
• MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
• 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
  • “aseptic processing”, “ethylene oxide gas sterilisation (EOG)”, “low temperature steam and formaldehyde sterilisation”, “moist heat sterilisation” and “radiation sterilisation (gamma, x-ray, electron beam)”
• MDS 1006 Reusable surgical instruments
• …
• 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
  • Restriction: Review of devices according to points 1, 3, 5 and 6 of Annex XVI to Regulation (EU) 2017/745 only.
• MDS 1013 Class III custom-made implantable devices
• MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device
• …
• MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
  • Excluding human origin.
• …
• MDT 2013 Devices which have undergone reprocessing

The full designation scope is available here.