European Commission - Growth

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Notification

Found : 41
 
  Body :

Eurofins Product Testing Italy S.r.l.
Via Courgnè, 21
10156 - TORINO (TO)
Country : Italy

Phone : +39 011 2222225
Fax : +39 011 2222226

Email : tech@eurofins.com
Website : http://tech.eurofins.it

Notified Body number : 0477

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 22/11/2018                 Version(s): 1 2 3 4

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, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0103 - Non-active orthopaedic and rehabilitation 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 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 type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0106 - Non-active instruments
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0107 - Contraceptive medical devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0110 - Non-active medical devices for ingestion
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC and/or utilising tissues of animal origin, including Commission Regulation (EU) N. 722/2012. 
*MD 0200 - Non-active implants
 
   - *MD 0202 - Non-active orthopaedic 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, except those classified in class III only as utlising tissues of animal origin, including Commission Regulation (EU) N. 722/2012. 
   - *MD 0203 - Non-active functional 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, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC and/or utilising tissues of animal origin, including Commission Regulation (EU) N. 722/2012. 
   - *MD 0204 - Non-active soft tissue 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, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC and/or utilising tissues of animal origin, including Commission Regulation (EU) N. 722/2012. 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0303 - Other medical devices for wound care
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices 
   - *MD 0402 - Dental materials
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Exclusion of class III medical devices, except those classified in class III only as incorporating medicinal substances, according to Directive 2001/83/EC 
   - *MD 0403 - Dental implants
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
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 
   - *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 1105 - 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 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 1109 - Active devices for patient positioning and transport
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 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 1402 - Devices utilising non-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 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 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC  
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013)  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition Including moist heat sterilization, aseptic processing, radiation sterilization,ethylene oxide gas sterilization (EOG)
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software