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. )
Date: 2017-11-23
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, cataloguing, harmonisation of standards, market approval, market supervision, marketing standard, medical device, research body, testing




L_2017309EN.01000701.xml










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