The NANDO database has a new Notified Body under the MDR!
MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745 on medical devices – MDR.
MTIC InterCert S.r.l.
Sede Legale: Via G.Leopardi, 14 – Sede Operativa: Via Moscova, 11
20123 – Milano (MI) – 20017 – Rho (MI)
Italy
+39 02 97071800
info@mtic-group.org
Body Number: 0068
The extract from the Notification:
- 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 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
- Excluding class III Medical Devices
- MDA 0315 Software
- Excluding class III Medical Devices
- MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
- MDA 0318 Other active non-implantable devices
- Excluding class III Medical Devices
- MDN 1103 Non-active dental implants and dental materials
- Excluding class III Medical Devices
- MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
- Excluding class III Medical Devices
- …
- MDS 1005 Devices in sterile condition
- Including: – ethylene oxide gas sterilisation (EOG) – low temperature steam – moist heat sterilisation – radiation sterilisation (gamma-ray, x-ray)
- MDS 1006 Reusable surgical instruments
- …
- MDT 2012 Devices which require installation, refurbishment
- Limited to devices which require installation
- MDT 2013 Devices which have undergone reprocessing
- Limited to reusable devices which have to undergone reprocessing
The full designation scope is available here.
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