MDR: 36 Notified Bodies on NANDO

The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR:

 

ICIM S.P.A.
Piazza Don Enrico Mapelli, 75
20099 – Sesto San Giovanni (MI)
Country: Italy

Phone: +39 02 725341
Fax: +39 02 72002098

Email: info@icim.it
Website: www.icim.it

Notified Body number: 0425

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

Codes reflecting the design and intended purpose of the device

A. Active devices

2. Active non-implantable devices for imaging, monitoring and/or diagnosis

• MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
• MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis

3. Active non-implantable therapeutic devices and general active non-implantable devices

• MDA 0305 Active non-implantable devices for stimulation or inhibition
  Excluded Class III Medical Devices
• MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
• MDA 0307 Active non-implantable respiratory devices
• MDA 0311 Active non-implantable dental devices
• MDA 0312 Other active non-implantable surgical devices
• MDA 0315 Software
• MDA 0316 Medical gas supply systems and parts thereof
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation

B. Non-active devices

1. Non-active implants and long term surgically invasive devices

• MDN 1102 Non-active osteo- and orthopaedic implants
  Excluded Class III Medical Devices
• MDN 1103 Non-active dental implants and dental materials

2. Non-active non-implantable devices

• MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
• MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
• MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
• MDN 1204 Non-active non-implantable devices for wound and skin care
• MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
• MDN 1206 Non-active non-implantable ophthalmologic devices
• MDN 1207 Non-active non-implantable diagnostic devices
• MDN 1208 Non-active non-implantable instruments
• MDN 1209 Non-active non-implantable dental materials
• MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
• MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

Horizontal technical competence

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 – Including: aseptic processing ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma-ray, x-ray, electron beam)
• MDS 1006 Reusable surgical instruments
• MDS 1007 Devices incorporating or consisting of nanomaterial
• 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 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
• MDT 2001 Devices manufactured using metal processing
• MDT 2002 Devices manufactured using plastic processing
• MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
• MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
• MDT 2006 Devices manufactured using chemical processing
• MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
• MDT 2008 Devices manufactured in clean rooms and associated controlled environments
• MDT 2010 Devices manufactured using electronic components including communication devices
• MDT 2011 Devices which require packaging, including labelling
• MDT 2012 Devices which require installation, refurbishment