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Notification

Found : 26
 
  Body :

SGS FIMKO OY
Takomotie 8
00380 HELSINKI
Country : Finland

Phone : +358 9 696 361
Fax : -

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

Notified Body number : 0598 (ex-0403)

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Last approval date : 05/03/2021
 

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Some information about the accreditation details are available in the PDF
Legislation
Regulation (EU) 2017/745 on medical devices    
Last approval date : 09/01/2021
Products Procedures Annexes Conditions
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
 
   - A. Active devices
 
   -
      - 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
         - MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   -
      - 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
         - MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, excluding ultrasound devices 
   -
      - 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
         - MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   -
      - 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
         - MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, excluding audiometers 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0301 Active non-implantable devices utilising ionizing radiation
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, excluding blood warmers 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, limited to extracorporeal shockwave therapy of limbs and joints and shockwave HIFU 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0305 Active non-implantable devices for stimulation or inhibition
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0307 Active non-implantable respiratory devices
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, excluding hyperbaric chambers 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0309 Active non-implantable ophthalmologic devices
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, excluding surgical devices 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0311 Active non-implantable dental devices
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, limited to hospital beds, physiotherapy equipment, rehabilitation, patient positioning and transport devices 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0315 Software
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb, limited to autoclaves 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0318 Other active non-implantable devices
Conformity assessment based on type-examination
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Conformity assessment based on product conformity verification
Annex X
Annex IX(I)
Annex IX(II)
Annex XI(A)
Annex XI(B)
Up to class IIb 
   - B. Non-active devices
 
   -
      - 2. Non-active non-implantable devices
         - MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
Up to class IIb 
   -
      - 2. Non-active non-implantable devices
         - MDN 1207 Non-active non-implantable diagnostic devices
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
Up to class IIb 
   -
      - 2. Non-active non-implantable devices
         - MDN 1208 Non-active non-implantable instruments
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
Up to class IIb 
   -
      - 2. Non-active non-implantable devices
         - MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
Up to class IIb 
   -
      - 2. Non-active non-implantable devices
         - MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
Up to class IIb 
 
Horizontal technical competence Limitations
MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)  
MDS 1005 Devices in sterile condition Aseptic Processing, Ethylene Oxide gas sterilization, Low temperature steam and formaldehyde sterilization, Low temperature H2O2 sterilization, Moist heat sterilization, Radiation sterilization (gamma, x-ray, electron beam)
MDS 1007 Devices incorporating or consisting of nanomaterial Up to class IIb
MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices  
MDS 1010 Devices with a measuring function  
MDS 1011 Devices in systems or procedure packs  
MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745  
MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device  
MDT 2001 Devices manufactured using metal processing  
MDT 2002 Devices manufactured using plastic processing  
MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)  
MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)  
MDT 2006 Devices manufactured using chemical processing  
MDT 2008 Devices manufactured in clean rooms and associated controlled environments  
MDT 2010 Devices manufactured using electronic components including communication devices  
MDT 2011 Devices which require packaging, including labelling  
MDT 2012 Devices which require installation, refurbishment