MDR: 39th Notified Body on NANDO!

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

You can find the full scope of its notification on the following link. Below is an extract from NANDO, where limitations are listed:

Horizontal technical competence

• MDS 1001 Devices incorporating medicinal substances
  • Excluding medicinal products derived from human blood or human plasma
• 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
  • Limitations: aseptic processing; ethylene oxide gas sterilisation (EOG); moist heat sterilisation; radiation sterilisation (gamma, x-ray, electron beam)
• 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 1013 Class III custom-made implantable devices
  • Limited to orthopaedic and opthalmological devices
• …
• MDT 2006 Devices manufactured using chemical processing
• MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
• …
• MDT 2012 Devices which require installation, refurbishment