CELEX: 32017R2185
Language: en
Date: 2017-11-23 00:00:00
Title: Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )

24.11.2017   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 309/7
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185
   of 23 November 2017
   on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Articles 39(10) and 42(13) thereof,
   Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (2), and in particular Articles 35(10) and 38(13) thereof,
   Whereas:
   
               (1)
            
            
               Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned. In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.
            
         
               (2)
            
            
               The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.
            
         
               (3)
            
            
               In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess. In order to facilitate such notification and the assessment of the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746, conformity assessment bodies should use the lists of codes and corresponding types of devices set out in this Regulation when applying for designation.
            
         
               (4)
            
            
               Experience shows that conformity assessment bodies applying for designation in the field of in vitro diagnostic medical devices also apply for designation for medical devices under Regulation (EU) 2017/745. It is therefore appropriate, for reasons of user-friendliness, to include the lists of codes for Regulation (EU) 2017/745 and for Regulation (EU) 2017/746 in one Implementing Regulation.
            
         
               (5)
            
            
               As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. In order to enable the conformity assessment bodies to use the codes laid down in this Regulation in the application for designation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.
            
         
               (6)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   List of codes
   1.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation.
   2.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation.
   Article 2
   Application for designation
   Conformity assessment bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746.
   Article 3
   Entry into force
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 November 2017.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 117, 5.5.2017, p. 1.
   
      (2)  OJ L 117, 5.5.2017, p. 176.
   
      ANNEX I
      
         The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745
      
      I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
      
      A.   Active devices
      
      1.   Active implantable devices
      
      
                  MDA CODE
               
               
                  Active implantable devices
               
            
                  MDA 0101
               
               
                  Active implantable devices for stimulation/inhibition/monitoring
               
            
                  MDA 0102
               
               
                  Active implantable devices delivering drugs or other substances
               
            
                  MDA 0103
               
               
                  Active implantable devices supporting or replacing organ functions
               
            
                  MDA 0104
               
               
                  Active implantable devices utilising radiation and other active implantable devices
               
            2.   Active non-implantable devices for imaging, monitoring and/or diagnosis
      
      
                  MDA CODE
               
               
                  Active non-implantable devices for imaging, monitoring and/or diagnosis
               
            
                  MDA 0201
               
               
                  Active non-implantable imaging devices utilising ionizing radiation
               
            
                  MDA 0202
               
               
                  Active non-implantable imaging devices utilising non-ionizing radiation
               
            
                  MDA 0203
               
               
                  Active non-implantable devices for monitoring of vital physiological parameters
               
            
                  MDA 0204
               
               
                  Other active non-implantable devices for monitoring and/or diagnosis
               
            3.   Active non-implantable therapeutic devices and general active non-implantable devices
      
      
                  MDA CODE
               
               
                  Active non-implantable therapeutic devices and general active non-implantable devices
               
            
                  MDA 0301
               
               
                  Active non-implantable devices utilising ionizing radiation
               
            
                  MDA 0302
               
               
                  Active non-implantable devices utilising non-ionizing radiation
               
            
                  MDA 0303
               
               
                  Active non-implantable devices utilising hyperthermia/hypothermia
               
            
                  MDA 0304
               
               
                  Active non-implantable devices for shock-wave therapy (lithotripsy)
               
            
                  MDA 0305
               
               
                  Active non-implantable devices for stimulation or inhibition
               
            
                  MDA 0306
               
               
                  Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
               
            
                  MDA 0307
               
               
                  Active non-implantable respiratory devices
               
            
                  MDA 0308
               
               
                  Active non-implantable devices for wound and skin care
               
            
                  MDA 0309
               
               
                  Active non-implantable ophthalmologic devices
               
            
                  MDA 0310
               
               
                  Active non-implantable devices for ear, nose and throat
               
            
                  MDA 0311
               
               
                  Active non-implantable dental devices
               
            
                  MDA 0312
               
               
                  Other active non-implantable surgical devices
               
            
                  MDA 0313
               
               
                  Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
               
            
                  MDA 0314
               
               
                  Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
               
            
                  MDA 0315
               
               
                  Software
               
            
                  MDA 0316
               
               
                  Medical gas supply systems and parts thereof
               
            
                  MDA 0317
               
               
                  Active non-implantable devices for cleaning, disinfection and sterilisation
               
            
                  MDA 0318
               
               
                  Other active non-implantable devices
               
            B.   Non-active devices
      
      1.   Non-active implants and long term surgically invasive devices
      
      
                  MDN CODE
               
               
                  Non-active implants and long term surgically invasive devices
               
            
                  MDN 1101
               
               
                  Non-active cardiovascular, vascular and neurovascular implants
               
            
                  MDN 1102
               
               
                  Non-active osteo- and orthopaedic implants
               
            
                  MDN 1103
               
               
                  Non-active dental implants and dental materials
               
            
                  MDN 1104
               
               
                  Non-active soft tissue and other implants
               
            2.   Non-active non-implantable devices
      
      
                  MDN CODE
               
               
                  Non-active non-implantable devices
               
            
                  MDN 1201
               
               
                  Non-active non-implantable devices for anaesthesia, emergency and intensive care
               
            
                  MDN 1202
               
               
                  Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
               
            
                  MDN 1203
               
               
                  Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
               
            
                  MDN 1204
               
               
                  Non-active non-implantable devices for wound and skin care
               
            
                  MDN 1205
               
               
                  Non-active non-implantable orthopaedic and rehabilitation devices
               
            
                  MDN 1206
               
               
                  Non-active non-implantable ophthalmologic devices
               
            
                  MDN 1207
               
               
                  Non-active non-implantable diagnostic devices
               
            
                  MDN 1208
               
               
                  Non-active non-implantable instruments
               
            
                  MDN 1209
               
               
                  Non-active non-implantable dental materials
               
            
                  MDN 1210
               
               
                  Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases
               
            
                  MDN 1211
               
               
                  Non-active non-implantable devices for disinfecting, cleaning and rinsing
               
            
                  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)
               
            
                  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
               
            
                  MDN 1214
               
               
                  General non-active non-implantable devices used in health care and other non-active non-implantable devices
               
            II.   HORIZONTAL CODES
      
      1.   Devices with specific characteristics
      
      
                  MDS CODE
               
               
                  Devices with specific characteristics
               
            
                  MDS 1001
               
               
                  Devices incorporating medicinal substances
               
            
                  MDS 1002
               
               
                  Devices manufactured utilising tissues or cells of human origin, or their derivatives
               
            
                  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
               
            
                  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
               
            
                  MDS 1013
               
               
                  Class III custom-made implantable devices
               
            
                  MDS 1014
               
               
                  Devices incorporating as an integral part an in vitro diagnostic device
               
            2.   Devices for which specific technologies or processes are used
      
      
                  MDT CODE
               
               
                  Devices for which specific technologies or processes are used
               
            
                  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
               
            
                  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
               
            
         (1)  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24).
   
   
      ANNEX II
      
         The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746
      
      I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
      
      1.   Devices intended to be used for blood grouping
      
      
                  IVR CODE
               
               
                  Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration
               
            
                  IVR 0101
               
               
                  Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]
               
            
                  IVR 0102
               
               
                  Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
               
            
                  IVR 0103
               
               
                  Devices intended to determine markers of the Kell system [Kel1 (K)]
               
            
                  IVR 0104
               
               
                  Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]
               
            
                  IVR 0105
               
               
                  Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]
               
            
                   
               
               
                  Other devices intended to be used for blood grouping
               
            
                  IVR 0106
               
               
                  Other devices intended to be used for blood grouping
               
            2.   Devices intended to be used for tissue typing
      
      
                  IVR CODE
               
               
                  Devices intended to be used for tissue typing
               
            
                  IVR 0201
               
               
                  Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration
               
            
                  IVR 0202
               
               
                  Other devices intended to be used for tissue typing
               
            3.   Devices intended to be used for markers of cancer and non-malignant tumours
      
      
                  IVR CODE
               
               
                  Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing
               
            
                  IVR 0301
               
               
                  Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
               
            
                  IVR 0302
               
               
                  Other devices intended to be used for markers of cancer and non-malignant tumours
               
            4.   Devices intended to be used for human genetic testing
      
      
                  IVR CODE
               
               
                  Devices intended to be used for human genetic testing
               
            
                  IVR 0401
               
               
                  Devices intended to be used in screening/confirmation of congenital/inherited disorders
               
            
                  IVR 0402
               
               
                  Devices intended to be used to predict genetic disease/disorder risk and prognosis
               
            
                  IVR 0403
               
               
                  Other devices intended to be used for human genetic testing
               
            5.   Devices intended to be used to determine markers of infections/immune status
      
      
                  IVR CODE
               
               
                  Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status
               
            
                  IVR 0501
               
               
                  Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents
               
            
                  IVR 0502
               
               
                  Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration
               
            
                  IVR 0503
               
               
                  Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
               
            
                  IVR 0504
               
               
                  Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging
               
            
                  IVR 0505
               
               
                  Devices intended to be used to grow/isolate/identify and handle infectious agents
               
            
                  IVR 0506
               
               
                  Other devices intended to be used to determine markers of infections/immune status
               
            6.   Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures
      
      
                  IVR CODE
               
               
                  Devices intended to be used for a specific disease
               
            
                  IVR 0601
               
               
                  Devices intended to be used for screening/confirmation of specific disorders/impairments
               
            
                  IVR 0602
               
               
                  Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
               
            
                  IVR 0603
               
               
                  Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
               
            
                  IVR 0604
               
               
                  Other devices intended to be used for a specific disease
               
            
                   
               
               
                  Devices intended to be used to define or monitor physiological status and therapeutic measures
               
            
                  IVR 0605
               
               
                  Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
               
            
                  IVR 0606
               
               
                  Devices intended to be used for non-infectious disease staging
               
            
                  IVR 0607
               
               
                  Devices intended to be used for detection of pregnancy or fertility testing
               
            
                  IVR 0608
               
               
                  Devices intended to be used for screening, determination or monitoring of physiological markers
               
            
                  IVR 0609
               
               
                  Other devices intended to be used to define or monitor physiological status and therapeutic measures
               
            7.   Devices which are controls without a quantitative or qualitative assigned value
      
      
                  IVR CODE
               
               
                  Controls without a quantitative or qualitative assigned value
               
            
                  IVR 0701
               
               
                  Devices which are controls without a quantitative assigned value
               
            
                  IVR 0702
               
               
                  Devices which are controls without a qualitative assigned value
               
            8.   Class A devices in sterile condition
      
      
                  IVR CODE
               
               
                  Class A devices in sterile condition
               
            
                  IVR 0801
               
               
                  Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
               
            
                  IVR 0802
               
               
                  Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
               
            
                  IVR 0803
               
               
                  Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
               
            II.   HORIZONTAL CODES
      
      1.   In vitro diagnostic devices with specific characteristics
      
      
                  IVS CODE
               
               
                  In vitro diagnostic devices with specific characteristics
               
            
                  IVS 1001
               
               
                  Devices intended to be used for near-patient testing
               
            
                  IVS 1002
               
               
                  Devices intended to be used for self-testing
               
            
                  IVS 1003
               
               
                  Devices intended to be used as companion diagnostics
               
            
                  IVS 1004
               
               
                  Devices manufactured utilising tissues or cells of human origin, or their derivatives
               
            
                  IVS 1005
               
               
                  Devices in sterile condition
               
            
                  IVS 1006
               
               
                  Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)
               
            
                  IVS 1007
               
               
                  Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)
               
            
                  IVS 1008
               
               
                  Instruments, equipment, systems or apparatus
               
            
                  IVS 1009
               
               
                  Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures
               
            
                  IVS 1010
               
               
                  Devices incorporating software/utilising software/controlled by software
               
            2.   In vitro diagnostic devices for which specific technologies are used
      
      
                  IVT CODE
               
               
                  In vitro diagnostic devices for which specific technologies are used
               
            
                  IVT 2001
               
               
                  In vitro diagnostic devices manufactured using metal processing
               
            
                  IVT 2002
               
               
                  In vitro diagnostic devices manufactured using plastic processing
               
            
                  IVT 2003
               
               
                  In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
               
            
                  IVT 2004
               
               
                  In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
               
            
                  IVT 2005
               
               
                  In vitro diagnostic devices manufactured using biotechnology
               
            
                  IVT 2006
               
               
                  In vitro diagnostic devices manufactured using chemical processing
               
            
                  IVT 2007
               
               
                  In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals
               
            
                  IVT 2008
               
               
                  In vitro diagnostic devices manufactured in clean rooms and associated controlled environments
               
            
                  IVT 2009
               
               
                  In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin
               
            
                  IVT 2010
               
               
                  In vitro diagnostic devices manufactured using electronic components including communication devices
               
            
                  IVT 2011
               
               
                  In vitro diagnostic devices which require packaging, including labelling
               
            3.   In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification
      
      
                  IVP CODE
               
               
                  In vitro diagnostic devices which require specific knowledge in examination procedures
               
            
                  IVP 3001
               
               
                  In vitro diagnostic devices which require knowledge regarding agglutination tests
               
            
                  IVP 3002
               
               
                  In vitro diagnostic devices which require knowledge regarding biochemistry
               
            
                  IVP 3003
               
               
                  In vitro diagnostic devices which require knowledge regarding chromatography
               
            
                  IVP 3004
               
               
                  In vitro diagnostic devices which require knowledge regarding chromosomal analysis
               
            
                  IVP 3005
               
               
                  In vitro diagnostic devices which require knowledge regarding coagulometry
               
            
                  IVP 3006
               
               
                  In vitro diagnostic devices which require knowledge regarding flow cytometry
               
            
                  IVP 3007
               
               
                  In vitro diagnostic devices which require knowledge regarding immunoassays
               
            
                  IVP 3008
               
               
                  In vitro diagnostic devices which require knowledge regarding lysis based testing
               
            
                  IVP 3009
               
               
                  In vitro diagnostic devices which require knowledge regarding measurement of radioactivity
               
            
                  IVP 3010
               
               
                  In vitro diagnostic devices which require knowledge regarding microscopy
               
            
                  IVP 3011
               
               
                  In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)
               
            
                  IVP 3012
               
               
                  In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry
               
            
                  IVP 3013
               
               
                  In vitro diagnostic devices which require knowledge regarding spectroscopy
               
            
                  IVP 3014
               
               
                  In vitro diagnostic devices which require knowledge regarding tests of cell function
               
            4.   In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification
      
      
                  IVD CODE
               
               
                  In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification
               
            
                  IVD 4001
               
               
                  In vitro diagnostic devices which require knowledge regarding bacteriology
               
            
                  IVD 4002
               
               
                  In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry
               
            
                  IVD 4003
               
               
                  In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)
               
            
                  IVD 4004
               
               
                  In vitro diagnostic devices which require knowledge regarding genetics
               
            
                  IVD 4005
               
               
                  In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders
               
            
                  IVD 4006
               
               
                  In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics
               
            
                  IVD 4007
               
               
                  In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology
               
            
                  IVD 4008
               
               
                  In vitro diagnostic devices which require knowledge regarding immunology
               
            
                  IVD 4009
               
               
                  In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics
               
            
                  IVD 4010
               
               
                  In vitro diagnostic devices which require knowledge regarding mycology
               
            
                  IVD 4011
               
               
                  In vitro diagnostic devices which require knowledge regarding parasitology
               
            
                  IVD 4012
               
               
                  In vitro diagnostic devices which require knowledge regarding virology