CELEX: 
Language: en
Date: 2017-11-23 00:00:00
Title: COMMISSION IMPLEMENTING REGULATION (EU) …/... 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

COMMISSION IMPLEMENTING REGULATION (EU) …/...
            
            
               of 23.11.2017
            
            
               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, 23.11.2017
            
            
               
                     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.
               
            
      
    ---documentbreak--- 
      
         
         
            
               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
            
            
            
               ICODES 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
                     
                  
               
            
               IIHORIZONTAL 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
                     
                  
                  
                     
                        
                              1
                           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
                     
                  
               
                     
                        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
                     
                  
               
               
            
               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
            
            
            
               ICODES 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)]
                     
                  
               
                     
                        IVR CODE
                     
                  
                  
                     
                        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
                     
                  
               
                     
                        IVR CODE
                     
                  
                  
                     
                        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 
                     
                  
               
            
               IIHORIZONTAL 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
                     
                  
               
         
         
            
                  
                     (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).