
Article 1 

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 
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 
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
ANNEX I
I.  A.  1. 

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. 

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. 

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.  1. 

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. 

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.  1. 

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
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. 

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
I.  1. 

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. 

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. 

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. 

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. 

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. 

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. 

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. 

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.  1. 

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. 

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. 

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. 

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
