MDR: 34 Notified Bodies on NANDO

The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR:

ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A – loc. Castello di Serravalle
40053 Valsamoggia (BO)
Country : Italy

Phone : +39 051 6705141
Fax : +39 051 6705156

Email : ecm@entecerma.it
Website : www.entecerma.it

Notified Body number : 1282

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

Below, an extract from NANDO, where conditions/limitations are listed, mostly for Class III medical devices:

• MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  
  • Excluding class III medical devices Limited to video endoscopes
• MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  
  • Excluding class III medical devices
• MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  
  • Excluding class III medical devices 
    
• MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • Excluding class III medical devices
• MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • Excluding class III medical devices
• MDA 0305 Active non-implantable devices for stimulation or inhibition
  • Excluding class III medical devices
• MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • Excluding class III medical devices Limited to infusion pump
• MDA 0307 Active non-implantable respiratory devices
  • Excluding class III medical devices
  • Excluding hyperbaric chambers
• MDA 0308 Active non-implantable devices for wound and skin care
  • Excluding class III medical devices
• MDA 0312 Other active non-implantable surgical devices
  • Excluding class III medical devices
• MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • Excluding class III medical devices Limited to devices for patient positioning and transport
• MDA 0315 Software
  • Excluding class III medical devices
• …
• …
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • Excluding class III medical devices Limited to moist heat sterilizers
• MDS 1005 Devices in sterile condition
  • Limited to aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation
• MDT 2013 Devices which have undergone reprocessing
  • Limited to reusable devices which have to undergone reprocessing

Under the designation scope without limitations:

• 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 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
• MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
• …
• …

---

Have a look at the Analysis of NB Designation prepared by our partners AKRA TEAM. You will find it in our dedicated Library of Documents – Notified Body: MDR and IVDR.

Do not forget to follow our dedicated LinkedIn page for all the updates!