(2) Active non-implantable devices for imaging, monitoring and/or diagnosis

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1 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 PURPOSE OF THE DEVICE A) ACTIVE DEVICES (1) Active implantable devices MDA CODE Active implantable devices MDA 0101 MDA 0102 MDA 0103 MDA 0104 Active implantable devices for stimulation / inhibition / monitoring Active implantable devices delivering drugs or other substances Active implantable devices substituting or replacing organ functions 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 MDA 0202 MDA 0203 MDA 0204 Active non-implantable imaging devices utilising ionizing radiation Active non-implantable imaging devices utilising non-ionizing radiation Active non-implantable devices for monitoring of vital physiological parameters 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 MDA 0302 MDA 0303 MDA 0304 MDA 0305 MDA 0306 MDA 0307 MDA 0308 MDA 0309 MDA 0310 MDA 0311 Active non-implantable devices utilising ionizing radiation Active non-implantable devices utilising non-ionizing radiation Active non-implantable devices utilising hyperthermia / hypothermia Active non-implantable devices for shock-wave therapy (lithotripsy) Active non-implantable devices for stimulation or inhibition Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemopheresis Active non-implantable respiratory devices Active non-implantable devices for wound and skin care Active non-implantable ophthalmologic devices Active non-implantable devices for ear, nose and throat Active non-implantable dental devices Komentář [VP1]: The definitions using the word other for remaining products not specifically mentioned in the list is unsuitable with regard to purpose of the list. According to the Article 2 of the proposed regulation, the Conformity assessment bodies (CAB) shall use the lists of codes when specifying the types of devices in the application for designation. However, the application shall be substantiated by an evidence of the CAB personnel qualification related to each code applied for. A proof of qualification in terms of educational branch, specific training and experience with assessment of precisely specified devices (e.g. MDA 0201 Active non-implantable imaging devices utilising ionizing radiation) can be submitted relatively easily. However a problem occurs whenever CAB applies for uncertain categories like MDN 1214 General non-active nonimplantable devices used in health care and other non-active non-implantable devices. What kind of education, what kind of training, what kind of experience with auditing and documentation assessment shall be submitted by notified body together with the application? How will be assessed the CAB s qualification for these uncertain categories/codes in course of a joint assessment? Answer to the above question is not easy. For this reason we recommend strongly to replace the uncertain categories/codes by one or more codes covering the remaining medical devices not mentioned already. Komentář [VP2]: See comment VP1 EN 1 EN

2 MDA 0312 MDA 0313 MDA 0314 MDA 0315 MDA 0316 MDA 0317 MDA 0318 Other active non-implantable surgical devices Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Standalone software B) Non-active devices Medical gas supply systems and parts thereof Active non-implantable devices for cleaning, disinfection and sterilisation Other active non-implantable devices (1) Non-active implants and long term surgically invasive devices MDN CODE Non-active implants and long term surgically invasive devices MDN 1101 MDN 1102 MDN 1103 MDN 1104 Non-active cardiovascular, vascular and neurovascular implants Non-active osteo- and orthopaedic implants Non-active dental implants and dental materials Non-active soft tissue and other implants Komentář [VP3]: A more detailed explanation should be suitable. For example: There is not clear, whether gas supply system covers whole gas distribution piping system being permanent part of the building, or only the piping from the wall outlet to a medical device administering the medicinal gas to the patient body. Komentář [VP4]: See the comment VP1 Komentář [VP5]: A specific category MDN 1105 Non-active ocular implants should be added covering intraocular lenses, long term contact lenses, orbital implants etc. Komentář [VP6]: See the comment VP1 (2) Non-active non-implantable devices MDN CODE Non-active non-implantable devices MDN 1201 MDN 1202 MDN 1203 MDN 1204 MDN 1205 MDN 1206 MDN 1207 MDN 1208 MDN 1209 MDN 1210 MDN 1211 MDN 1212 MDN 1213 MDN 1214 Non-active non-implantable devices for anaesthesia, emergency and intensive care Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools Non-active non-implantable devices for wound and skin care Non-active non-implantable orthopaedic and rehabilitation devices Non-active non-implantable ophthalmologic devices Non-active non-implantable diagnostic devices Non-active non-implantable instruments Non-active non-implantable dental materials Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases Non-active non-implantable devices for disinfecting, cleaning and rinsing 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) Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route General non-active non-implantable devices used in health care and other non-active nonimplantable devices Komentář [VP7]: This specification is not unambiguous one. It could cover either devices for disinfecting, cleaning and rinsing of medical devices and surfaces of an operating theatre or devices for disinfecting, cleaning and rinsing of wounds and patient s skin. Komentář [VP8]: See the comment VP1 plus the following general remark: Generally, the need for explanation and examples of devices in certain or all categories/codes is apparent. Depending on point of view, lot of medical devices could be assigned to different MDA or MDN codes. In order to prevent such unwanted situation, an ANNEX III with examples of medical devices belonging to certain codes shall be added to this Regulation. EN 2 EN

3 II HORIZONTAL CODES (1) Devices with specific characteristics MDS CODE MDS 1001 MDS 1002 MDS 1003 Devices with specific characteristics Devices incorporating medicinal substances Devices manufactured utilising tissues or cells of animal origin, or their derivatives Devices manufactured utilising tissues or cells of human 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 MDS 1006 MDS 1007 MDS 1008 MDS 1009 MDS 1010 MDS 1011 MDS 1012 MDS 1013 MDS 1014 Devices in sterile condition Reusable surgical instruments Devices incorporating or consisting of nanomaterial Devices utilising biological 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 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 Devices with a measuring function Devices in systems or procedure packs Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 Class III custom-made implantable devices Devices incorporating as an integral part an in vitro diagnostic device Komentář [VP9]: An explanation would be necessary, whether or not the firmware written on memory chips (ROM EPROM etc.) being integrated parts of the device is also belonging to this category. (2) Devices for which specific technologies or processes have been used 1 MDT CODE Devices for which specific technologies or processes have been used MDT 2001 MDT 2002 MDT 2003 MDT 2004 MDT 2005 MDT 2006 MDT 2007 MDT 2008 Devices which require metal processing Devices which require plastic processing Devices which require non-metal mineral processing such as glass, ceramics Devices which require non-metal non-mineral processing such as textiles, rubber, leather, paper Devices which require the use of biotechnology Devices which require chemical processing Devices which require the production of pharmaceuticals or knowledge regarding the production of pharmaceuticals Devices which require clean room production 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 , p. 24). Komentář [VP10]: Rubber shall belong rather to the MDT 2002 Devices which require plastics and rubber processing, because chemically the same polymer can appear in plastic and elastic state, in dependency on the temperature and shear stress applied. (look on the literature regarding viscoelasticity and viscoelastic behaviour). Therefore, the separating of plastics and rubber into different codes is incorrect. Komentář [VP11]: Certain duplicity with the code MDS 1001 EN 3 EN

4 MDT 2009 MDT 2010 MDT 2011 MDT 2012 MDT 2013 Devices which require processing of materials of human or animal origin Devices which require manufacture or processing of electronic components including communication devices Devices which require packaging, including labelling Devices which require installation, refurbishment Devices which have undergone reprocessing EN 4 EN

5 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 PURPOSE OF THE DEVICE (1) Devices intended to be used for blood grouping IVR 0101 IVR 0102 IVR 0103 IVR 0104 IVR 0105 IVR 0106 Devices intended to be used for blood grouping to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration Devices intended to be used for blood grouping with regard to ABO system [A (ABO1), B (ABO2), AB (ABO3)] Devices intended to be used for blood grouping with regard to Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)] Devices intended to be used for blood grouping with regard to Kell system [Kel1 (K)] Devices intended to be used for blood grouping with regard to Kidd system [JK1 (Jka), JK2 (Jkb)] Devices intended to be used for blood grouping with regard to Duffy system [FY1 (Fya), FY2 (Fyb)] Other devices for blood grouping to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, referred to in point 2.2 (rule 2) of Annex VIII to Regulation (EU) 2017/746 Other devices intended to be used for blood grouping IVR 0107 Devices intended to be used for blood grouping, other than those referred to in point 2.2 (rule 2) of Annex VIII to Regulation (EU) 2017/746 Komentář [VP12]: See comment VP1 (2) Devices intended to be used for tissue typing IVR 0201 IVR 0202 IVR 0203 Devices intended to be used for tissue typing Devices intended to be used for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration (HLA A, B, DR) Other devices intended to be used for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, referred to in point 2.2 (rule 2) of Annex VIII to Regulation (EU) 2017/746 Devices intended to be used for tissue typing, other than those referred to in point 2.2 (rule 2) of Annex VIII to Regulation (EU) 2017/746 Komentář [VP13]: See comment VP1 EN 5 EN

6 (3) Devices intended to be used for markers of cancer and non-malignant tumours IVR 0301 Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing Devicesintended 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 Komentář [VP14]: The category description Devices intended to be used in screening, diagnosis, staging or monitoring of non-malignant tumours is more suitable, because the IVR 0301 deals with the cancer already. IVR 0401 IVR 0402 IVR 0403 Devices intended to be used for human genetic testing Devices intended to be used in screening / confirmation of congenital / inherited disorders Devices intended to be used to predict genetic disease risk and prognosis Other devices intended to be used for human genetic testing Komentář [VP15]: See VP1 (5) Devices intended to be used to determine markers of infections / immune status IVR 0501 IVR 0502 IVR 0503 IVR 0504 IVR 0505 IVR 0506 Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents 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 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents 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 Devices intended to be used to grow / isolate / identify and handle infectious agents Other devices intended to be used to determine markers of infections / immune status Komentář [VP16]: See VP1 (6) Devices intended to be used for non-infectious pathologies, physiological markers, and disorders / impairments (except human genetic testing) IVR 0601 IVR 0602 IVR 0603 Devices intended to be used for a specific disease Devices intended to be used for screening / confirmation of specific disorders / impairments Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances EN 6 EN

7 IVR 0604 IVR 0605 IVR 0606 IVR 0607 IVR 0608 IVR 0609 Other devices intended to be used for a specific disease Devices intended to be used to define or monitor physiological status and therapeutic measures Devices intended to be used for monitoring of levels of medicinal products, substances or biological components Devices intended to be used for non-infectious disease staging Devices intended to be used for detection of pregnancy or fertility testing Devices intended to be used for screening, determination or monitoring of physiological markers Other devices intended to be used to define or monitor physiological status and therapeutic measures Komentář [VP17]: See VP1 Komentář [VP18]: See VP1 (7) Devices which are controls without a quantitative or qualitative assigned value IVR 0701 IVR 0702 Controls without a quantitative or qualitative assigned value Devices which are controls without a quantitative assigned value Devices which are controls without a qualitative assigned value (8) Class A devices in sterile condition IVR 0801 IVR 0802 IVR 0803 Class A devices in sterile condition Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 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 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 IVS 1001 IVS 1002 IVS 1003 IVS 1004 In vitro diagnostic devices with specific characteristics Devices intended to be used for near-patient testing Devices intended to be used for self-testing Devices intended to be used as companion diagnostics Devices utilizing material of human origin EN 7 EN

8 IVS 1005 Devices in sterile condition IVS 1006 Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746) IVS 1007 IVS 1008 IVS 1009 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) Instruments, equipment, systems or apparatus Software independent of any other device 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 have been used Komentář [VP19]: An explanation would be necessary, whether or not the firmware written on memory chips (ROM EPROM etc.) being integrated parts of the device is also belonging to this category. IVT CODE IVT 2001 IVT 2002 IVT 2003 IVT 2004 IVT 2005 IVT 2006 IVT 2007 IVT 2008 IVT 2009 IVT 2010 IVT 2011 In vitro diagnostic devices for which specific technologies have been used In vitro diagnostic devices which require metal processing In vitro diagnostic devices which require plastic processing In vitro diagnostic devices which require non-metal mineral processing such as glass, ceramics In vitro diagnostic devices which require non-metal non-mineral processing such as textiles, rubber, leather, paper In vitro diagnostic devices which require the use of biotechnology In vitro diagnostic devices which require chemical processing In vitro diagnostic devices which require production of pharmaceuticals or knowledge regarding the production of pharmaceuticals In vitro diagnostic devices which require clean room production In vitro diagnostic devices which require processing of materials of human, animal or microbial origin In vitro diagnostic devices which require manufacture or processing of electronic components including communication devices In vitro diagnostic devices which require packaging, including labelling Komentář [VP20]: Rubber shall belong rather to the IVT 2002 In vitro diagnostic devices which require plastics and rubber processing, because chemically the same polymer can appear in plastic and elastic state, in dependency on the temperature and shear stress applied. (look on the literature regarding viscoelasticity and viscoelastic behaviour). Therefore, the separating of plastics and rubber into different codes is incorrect. (3) In vitro diagnostic devices which require specific knowledge in examination procedures IVP CODE IVP 3001 IVP 3002 In vitro diagnostic devices which require specific knowledge in examination procedures In vitro diagnostic devices which require knowledge regarding agglutination tests In vitro diagnostic devices which require knowledge regarding biochemistry EN 8 EN

9 IVP 3003 IVP 3004 IVP 3005 IVP 3006 IVP 3007 IVP 3008 IVP 3009 IVP 3010 IVP 3011 IVP 3012 IVP 3013 IVP 3014 In vitro diagnostic devices which require knowledge regarding chromatography In vitro diagnostic devices which require knowledge regarding chromosomal analysis In vitro diagnostic devices which require knowledge regarding coagulometry In vitro diagnostic devices which require knowledge regarding flow cytometry In vitro diagnostic devices which require knowledge regarding immunoassays In vitro diagnostic devices which require knowledge regarding lysis based testing In vitro diagnostic devices which require knowledge regarding measurement of radioactivity In vitro diagnostic devices which require knowledge regarding microscopy In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS) In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry In vitro diagnostic devices which require knowledge regarding spectroscopy 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 IVD 4100 IVD 4101 IVD 4102 IVD 4103 IVD 4104 In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification In vitro diagnostic devices which require knowledge regarding bacteriology - Multi-drug-resistant mycobacterium species (tuberculosis) - Vibrio cholerae (cholera) - Multi-resistant staphylococcus aureus (and/or tests for resistance genes) - Treponema pallidum (syphilis) IVD 4200 In vitro diagnostic devices which require knowledge regarding clinical chemistry / biochemistry IVD 4300 IVD 4301 IVD 4400 IVD 4500 In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses) - Prion (Creutzfeldt-Jakob disease (CJD) and variant CJD (vcjd)) In vitro diagnostic devices which require knowledge regarding genetics In vitro diagnostic devices which require knowledge regarding haematology / haemostasis, including coagulation disorders EN 9 EN

10 IVD 4600 In vitro diagnostic devices which require knowledge regarding histocompatability and immunogenetics IVD 4700 In vitro diagnostic devices which require knowledge regarding immunohistochemistry / histology IVD 4800 In vitro diagnostic devices which require knowledge regarding immunology IVD 4900 In vitro diagnostic devices which require knowledge regarding molecular biology / diagnostics IVD 5000 IVD 5100 IVD 5101 IVD 5102 IVD 5103 IVD 5200 IVD 5201 IVD 5202 IVD 5203 IVD 5204 IVD 5205 IVD 5206 IVD 5207 IVD 5208 IVD 5209 IVD 5210 In vitro diagnostic devices which require knowledge regarding mycology In vitro diagnostic devices which require knowledge regarding parasitology - Plasmodium species (malaria) - Toxoplasma gondii (toxoplasmosis) - Trypanosoma cruzi (Chagas disease) In vitro diagnostic devices which require knowledge regarding virology - Cytomegalovirus (CMV IgG) - Epstein-Barr virus (EBV) - Hepatitis B, C, D, E - Highly virulent pandemic influenza - HIV 1 &2 (HIV/AIDS) - Human T-lymphotropic virus (HTLV) - SARS - coronavirus (SARS) - Lassa fever virus, Ebola virus, Marburg virus (viral haemorrhagic fevers) - West Nile virus (West Nile fever) - Zika virus (Zika fever) EN 10 EN