COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185

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 * * *