MDR: 48th Notified Body on NANDO!

The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days!

The extract from the Notification:

• MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • • Excluding gamma cameras
• 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 0302 Active non-implantable devices utilising non-ionizing radiation
• MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • Excluding cryotherapy devices
• MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
• 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
  • Excluding ECMO and blood pumps
• MDA 0307 Active non-implantable respiratory devices
• MDA 0308 Active non-implantable devices for wound and skin care
  • Limited to wound therapy devices and cryotherapy equipment
• …
• MDA 0315 Software
• …
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
• MDA 0318 Other active non-implantable devices
• …
• MDN 1103 Non-active dental implants and dental materials
  • Limited to dental materials
• MDN 1104 Non-active soft tissue and other implants
  • Excluding breast implant and other non-filler restorative implants, bariatric surgery devices
• …
• MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
  • Excluding orthoses
• MDN 1206 Non-active non-implantable ophthalmologic devices
  • Excluding instruments used in ophthalmology
• MDN 1207 Non-active non-implantable diagnostic devices
  • Limited to measurement cups
• …
• …
• MDS 1001 Devices incorporating medicinal substances
  • Excluding plasma and blood 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
  • Limited to aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilization, radiation sterilisation (gamma, x-ray, electron beam), sterilisation with hydrogen peroxide
• MDS 1006 Reusable surgical instruments
• …
• 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 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • Limited to MDR Annex XVI clause 1,2 and 3 devices
• MDS 1013 Class III custom-made implantable devices
  • Limited to orthopedics and trauma implants
• …
• …
• MDT 2013 Devices which have undergone reprocessing
  • Limited to reusable devices which have to undergone reprocessing

The full designation scope is available here.