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Notification

Found : 21
 
  Body :

DARE!! Services B.V.
Vijzelmolenlaan 7
NL-3447 GX Woerden
Country : Netherlands

Phone : +31(0)348 430 979
Fax : +31(0)348 430 645

Email : certifications@dare.nl
Website : www.dare.nl

Notified Body number : 1912

 

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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 : 05/11/2019
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 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)
 
   -
      - 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)
 
   -
      - 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)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0302 Active non-implantable 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)
 
   -
      - 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)
 
   -
      - 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)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
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)
Limited to devices for administration and removal of substances  
   -
      - 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)
Excluding inhalation anaesthesia devices, lung ventilators and heart-lung machines  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0308 Active non-implantable devices for wound and skin care
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)
 
   -
      - 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)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0310 Active non-implantable devices for ear, nose and throat
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)
 
   -
      - 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)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0312 Other active non-implantable surgical 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)
 
   -
      - 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)
 
   -
      - 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
Annex IX(I)
Annex IX(II)
 
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0316 Medical gas supply systems and parts thereof
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)
 
   -
      - 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)
 
 
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 Limited to ethylene oxide gas sterilisation and radiation sterilisation
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 Only for active devices
MDS 1010 Devices with a measuring function  
MDS 1011 Devices in systems or procedure packs Only devices in systems, procedure packs are excluded
MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 Only for active devices. Code will be only applicable as of the date of application of the relevant common specifications referred to in Article 1(2) of the MDR.
MDT 2001 Devices manufactured using metal processing  
MDT 2002 Devices manufactured using plastic 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