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Notification

Found : 37
 
  Body (History):

IRCM ISTITUTO DI RICERCHE E COLLAUDI MASINI S.R.L.
Via G.Leopardi, 14
20123 - Milano (MI)
Country : Italy

Phone : +39 02 9301517
Fax : +39 02 9308176

Email : istitutomasini@istitutomasini.it
Website : www.istitutomasini.it

Notified Body number : 0068

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Last approval date : 22/05/2017
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last approval date : 08/09/2014                 Version(s): 1 2

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 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
Except class III Medical Devices 
   - *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
Except class III Medical Devices 
   - *MD 0104 - Non-active medical devices with measuring function
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
Except 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
Except class III Medical Devices 
   - *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
Except class III Medical Devices 
   - *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
Except 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
Except class III Medical Devices 
*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
Except 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
Except class III Medical Devices 
   - *MD 0302 - Suture material and clamps
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
Except class III Medical Devices Except suture material 
*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
Except 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
Except 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
Except class III Medical Devices 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
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
Except class III Medical Devices 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
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
Except class III Medical Devices Except hyperbaric chambers 
   - *MD 1103 - Devices for stimulation or inhibition
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
Except class III Medical Devices 
   - *MD 1104 - Active surgical 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
Except class III Medical Devices 
   - *MD 1105 - 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
Except class III Medical Devices 
   - *MD 1106 - Active dental 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
Except 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
Except class III Medical Devices 
   - *MD 1108 - Active rehabilitation devices and active prostheses
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
Except class III Medical Devices Except active prostheses 
   - *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
Except class III Medical Devices 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
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
Except class III Medical Devices 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
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
Except class III Medical Devices 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
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
Except class III Medical Devices 
   - *MD 1302 - Monitoring devices of vital physiological parameters
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
Except class III Medical Devices 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
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
Except class III Medical Devices 
   - *MD 1402 - Devices utilising non-ionizing radiation
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
Except class III Medical Devices 
   - *MD 1403 - Devices for hyperthermia / hypothermia
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
Except class III Medical Devices Except Devices for hypothermia 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery Except class III Medical Devices
*MDS 7005 - Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Except class III Medical Devices
*MDS 7006 - Medical devices in sterile condition Except class III Medical Devices