European Commission - Growth

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Notification

Found : 32
 
  Body :

BUREAU VERITAS ITALIA S.P.A.
Viale Monza, 347
20126 - MILANO (MI)
Country : Italy

Phone : +39 02 270911
Fax : +39 02 2552980

Email : info.bv.italia@it.bureauveritas.com
Website : www.bureauveritas.it

Notified Body number : 1370

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Last approval date : 07/03/2018
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 06/05/2019                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0105 - Non-active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0106 - Non-active instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0110 - Non-active medical devices for ingestion
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0303 - Other medical devices for wound care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0402 - Dental materials
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0403 - Dental implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices - excluding hyperbaric chambers for oxygen therapy 
   - *MD 1103 - Devices for stimulation or inhibition
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices  
   - *MD 1104 - Active surgical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1106 - Active dental devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1107 - Active devices for disinfection and sterilisation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1112 - Medical gas supply systems and parts thereof
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas sterilization (EOG), moist heat sterilization, radiation sterilization (gamma, x-ray, electron beam), low temperature steam.
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software