MDR: 49th Notified Body on NANDO!

The NANDO database now includes the first Austrian MDR Notified Body, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to 49. Details about the newly designated NB:

QMD Services GmbH

Zelinkagasse 10/3

1010 Vienna

Austria

+43 1 533 0077

office@qmdservices.com

https://www.qmdservices.com/

Body Number: 2962

The extract from the Notification:

• MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
• MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • Excluding: audiometers; ocular tonometer; retinal cameras
• MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • Excluding: lasers for pain treatment; patient photo therapy; robotic solution for the non-invasive echotherapy treatment of varicose veins; surgical laser for refractive surgery of the eye
• MDA 0305 Active non-implantable devices for stimulation or inhibition
  • Excluding: electrical acupuncture.
• MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • Excluding: blood pumps for heart-lung machines
• MDA 0307 Active non-implantable respiratory devices
  • Excluding: hyperbaric chambers
• MDA 0312 Other active non-implantable surgical devices
  • Excluding: pressure regulators for spraying surgical sealants/haemostats
• MDA 0315 Software
  • Excluding: radiotherapy planning system
• MDA 0318 Other active non-implantable devices
• MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
• MDN 1102 Non-active osteo- and orthopaedic implants
  • Excluding: artificial spinal disc; prosthetic joint replacements (i.e. knee, hip implants); hyaluronic acid implant for intraarticular use; ligament reconstruction products (synthetic).
• MDN 1104 Non-active soft tissue and other implants
  • Limited to hernia meshes, urethral stent implants, sutures, collagen soft implants, adhesion (scarring) prevention implants; surgical hemostats and sealants/collagen-based hemostats
• …
• MDS 1005 Devices in sterile condition
  • Aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
• MDS 1006 Reusable surgical instruments
• MDS 1011 Devices in systems or procedure packs
• MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device
• …

The full designation scope is available here.