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Notification
Found : 47
 
  Body (History):

DEKRA Certification GmbH
Handwerkstraße 15
70565 STUTTGART
Country : Germany

Phone : +49 711 / 7861 1947
Fax : +49 711 / 7861 3450

Email : medizinprodukte.certification.de@dekra.com
Website : www.dekra-certification.de

Notified Body number : 0124

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

Last approval date : 18/05/2015
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
Regulation (EU) 2017/745 on medical devices     (History)
Last approval date : 14/08/2019                 Version(s): 1 2

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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 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 a quality management system
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex XI(A)		  
   -
      - 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 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0307 Active non-implantable respiratory devices
 Conformity assessment based on a quality management system
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex XI(A)		  
   -
      - 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 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0309 Active non-implantable ophthalmologic 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)		  
   -
      - 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 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0311 Active non-implantable dental 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0312 Other active non-implantable surgical 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)		  
   -
      - 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 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
 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)		 excluding IVF and ART; limited to devices for cryopreservation 
   -
      - 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		 Annex IX(I)
Annex IX(II)
Annex XI(A)		  
   -
      - 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 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)		  
   -
      - 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 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)		  
   -
      - 3. Active non-implantable therapeutic devices and general active non-implantable devices
         - MDA 0318 Other 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)		  
   - B. Non-active devices
  
   -
      - 1. Non-active implants and long term surgically invasive devices
         - MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
 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)		  
   -
      - 1. Non-active implants and long term surgically invasive devices
         - MDN 1102 Non-active osteo- and orthopaedic implants
 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)		  
   -
      - 1. Non-active implants and long term surgically invasive devices
         - MDN 1103 Non-active dental implants and dental materials
 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)		  
   -
      - 1. Non-active implants and long term surgically invasive devices
         - MDN 1104 Non-active soft tissue and other implants
 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)		 excluding breast implants whose purpose is the enlargement or replacement of the volume of the breast 
   -
      - 2. Non-active non-implantable devices
         - MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1204 Non-active non-implantable devices for wound and skin care
 Conformity assessment based on a quality management system
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex XI(A)		  
   -
      - 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1206 Non-active non-implantable ophthalmologic 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)		  
   -
      - 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)		  
   -
      - 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1209 Non-active non-implantable dental materials
 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases
 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)		  
   -
      - 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
 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)		  
   -
      - 2. Non-active non-implantable devices
         - MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
 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)		 excluding devices for ingestion 
   -
      - 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)		  
 
Horizontal technical competence Limitations
MDS 1001 Devices incorporating medicinal substances  
MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives restricted to devices manufactured utilising human serum albumin (HSA)
MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives  
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 including aseptic processing; ethylene oxide gas sterilisation (EOG); low temperature steam and formaldehyde sterilisation; moist heat sterilisation; radiation sterilisation (gamma, x-ray, electron beam); sterilisation with hydrogen peroxide; sterilisation with liquid chemical sterilising agens;
MDS 1006 Reusable surgical instruments  
MDS 1007 Devices incorporating or consisting of nanomaterial  
MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body  
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 only products within the designation according to MDA/MDN-codes excluding products according to section 3 of annex XVI
MDS 1013 Class III custom-made implantable devices only products within the designation according to MDA/MDN-codes
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 2005 Devices manufactured using biotechnology  
MDT 2006 Devices manufactured using chemical processing  
MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals  
MDT 2008 Devices manufactured in clean rooms and associated controlled environments  
MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin only products within the designation according to MDA/MDN-codes
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  
MDT 2013 Devices which have undergone reprocessing excluding reprocessing of single-use devices