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Notification

Found : 32
  Body :

SGS FIMKO OY
P.O. Box 30 (Särkiniementie 3)
00211 HELSINKI
Country : Finland

Phone : +358 9 696 361
Fax : +358 9 692 5474

Email : sgs.fimko@sgs.com
Website : www.fi.sgs.com

Notified Body number : 0598

Version(s): 1 2 3 4 5

Last update : 13/09/2013
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 23/08/2013                 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 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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (product quality assurance)
Annex II
Annex VI
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
*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
II: Up to class IIb only 
*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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
*MD 1100 - General active 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
II: Up to class IIb only; III, IV: Hyperbaric chambers only 
   - *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
II: Up to class IIb only; III, IV: Nerve and muscle stimulator only 
   - *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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
   - *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
II: Up to class IIb only; III, IV: Dental units and dental patient chairs only 
   - *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
II: Up to class IIb only 
   - *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
II: Up to class IIb only; III, IV: Neurological and muscular rehabilitation devices only 
   - *MD 1109 - Active devices for patient positioning and transport
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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
*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
II: Up to class IIb only; III, IV: X-ray devices only 
   - *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
II: Up to class IIb only; III, IV: Magnetic resonance imaging (MRI) devices only 
*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
II: Up to class IIb only 
   - *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
II: Up to class IIb only 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - 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
II: Up to class IIb only 
   - *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
II: Up to class IIb only; III, IV: Surgical ultrasoud devices only 
   - *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
II: Up to class IIb only 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery II: Up to class IIb only
*MDS 7006 - Medical devices in sterile condition II: Up to class IIb only
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