MDCG 2021-14 Rev.0
Explanatory note on IVDR codes
Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
1 Introduction
Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746. These codes are primarily used by designating authorities to define the notified body (NB) scope of designation but they are also used by the NB to:
1) describe the individual qualification of the NB’s staff members
2) describe the qualification required for assessing a device.
It is acknowledged that these codes may be broad, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device may not always be straightforward. However, the NB’s system needs to ensure, in all cases, that the authorisation of personnel and allocation of teams for the conformity assessment of a device ensures adequate knowledge and expertise.
2 Scope
The lists of codes and corresponding types of in vitro diagnostic medical devices (IVD) established by the above mentioned Regulation, namely, in its Annex II, takes into account various device types which can be characterised by design and intended purpose including companion diagnostics devices, devices for self-testing or for near patient testing, as well as by manufacturing processes and technologies used, such as sterilisation.
These lists of codes should be used in a way which allows a multi-dimensional application to all typology of devices. This will ensure that NB as well as the personnel assigned to conformity assessment are fully competent for the devices they are required to assess.
This guidance is intended to explain the different levels of codes and how they should be used, including the use of conditions to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.
3 Assignment of codes to IVDs within the conformity assessment procedure
When a manufacturer lodges an application with a NB, the type of devices and technologies subject to conformity assessment activities are to be indicated. Usually, at the application review stage (as defined in section 4.3 of Annex VII IVDR), NB will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves. This verification is carried out in order to ensure that the NB is able to assess the application based on its designation, and that it has available resources to carry out the relevant conformity assessment activities (feasibility evaluation). The final assignment is made by the NB.
After this application review, and signing of the contract, the NB will allocate appropriately qualified and authorised personnel to carry out audit activities or product reviews. (1)
The following table presents an overview of the different types of codes and a summary of the main characteristics of each of them for the assignment to specific devices and the allocation of resources.
Type Code | Assignment of codes to the device | Relevance for allocation of conformity assessment team |
|---|---|---|
IVR | Exactly 1 code per device.* The code should be selected according to the order in Regulation 2017/2185. If more than 1 IVR code is applicable, the one that is first in the list should be selected. | Allocation of personnel involved in the review of technical documentation (e.g. product reviewers) or in audits concerning product related aspects. |
IVS | 0 to several per device. Assign all codes applicable to the device. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. May also be applicable to staff performing audits concerning certain special processes.** |
IVT | 1 to several per device Assign the codes which describe the main production technologies. Select once an IVR code has been assigned. | Allocation of personnel involved in audits (e.g. site auditors involved in the auditing of metal processing). |
IVP | 1 to several per device*** Assign the codes which describe the main examination procedures. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. |
IVD | 0 to several per device Assign the codes which describe the main laboratory and clinical disciplines. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. |
* Note: Cases may exist in which more than one IVR code is assigned (please refer to examples 1 and 2, section 3.1)
** Note: Assessment of these processes could be performed by product reviewers or site auditors depending on their competence and the NB’s system
*** Note: Exceptional cases may exist that no IVP code is assigned (e.g. controls or specimen receptacles)
3.1 IVR codes
IVR codes reflect the design and intended purpose of the device and hence are mostly relevant for the allocation of personnel involved in the review of technical documentation. In some specific cases, the NB may assign product reviewers to assess device performance and safety aspects during an audit. This means that if there are device related issues to be audited and the auditors do not possess the required qualification, product reviewers who are qualified for the device in question should be part of the audit team.
The NB needs to ensure that the personnel allocated to the project are competent to assess for the devices and technologies under assessment.
The IVR codes may specify a field of in vitro diagnostic medical application (e.g. IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders). There are cases where more than one specific code might apply to a device. In addition, where there is a broad intended purpose, several codes may apply. Having these issues in mind, the codes were put in order such that the first applicable code in the list is the one to be selected. For example, when codes IVR 0201 and IVR 0202 both apply, the IVR 0201 code should be used. This approach ensures consistent assignment of codes (and therefore consistent assignment of suitably qualified staff) to devices.
Note that, given the complexity and the diversity of in vitro diagnostic medical devices, in exceptional cases deviations from the guidance given above may be necessary when assigning codes to devices in order to ensure suitably qualified staff in the conformity assessment. In such cases, a brief rationale shall be documented (see Example 1).
It is relatively common for IVD devices to be ‘multiplexed’. Such devices are composed of different “components”. In the case of multiplexed devices, it may not be possible to define a main intended purpose or main technological principle. In many cases, such equally important components of multiplexed assays will still fall under the same code. Nevertheless, in some cases, the components of multiplexed assays would not fall under the same IVR code, if they were devices on their own. As the components may be considered equally important, a single code, selected from the first applicable code, cannot be assigned. In such an exceptional case, assignment of several IVR codes can be considered, if the properties and risks of the device cannot appropriately be covered with one IVR code alone, even in conjunction with the relevant IVS, IVT and IVD codes (see Example 2). Therefore, the NB needs to ensure that the assigned staff is qualified to assess all components of the device.
Example 1: BRCA1 device intended for the detection of deletions or duplications in the human BRCA1 gene in order to confirm a potential cause and clinical diagnosis for hereditary breast and ovarian cancer and for molecular genetic testing of at-risk family members. According to the order mentioned above, this IVD falls into IVR 0300 codes. Nevertheless, additional competence regarding genetic testing would still be necessary (IVR 0400 codes). All relevant aspects may not be covered by one IVR code in conjunction with the relevant IVS, IVT, IVP and IVD codes.
Example 2: Multiplexed assay for gastrointestinal diseases/symptoms, combining assays for gastrointestinal pathogens with assays for digestive enzymes, immunochemical markers of food intolerances/sensitivities, markers of inflammation, or markers of gastric or colon cancers. This IVD may fall into IVR 0300, IVR 0500 and IVR 0600 codes. Use of several IVR codes is necessary to cover all aspects.
3.2 IVS codes
IVS codes are horizontal codes that are applicable to devices with specific characteristics. All codes that are applicable need to be assigned to a device in order to ensure that the review team possesses the full set of qualifications necessary for the conformity assessment. The IVS codes are primarily relevant for the allocation of personnel involved in the review of technical documentation. For some of the IVS codes the auditing aspects have their corresponding IVT code for the relevant technology (e.g. IVS 1004 Devices manufactured utilising tissues or cells of human origin, or their derivatives vs IVT 2009 In vitro diagnostic devices manufactured using processing of materials of human, animal and microbial origin). However, IVS codes may also be applicable to staff performing audits concerning certain special processes (for example IVS 1005 for staff auditing ethylene oxide sterilisation processes).
Medical device software which are devices in their own right (2) including software apps, software for data analysis, and for defining or monitoring therapeutic measures should be assigned to code IVS 1009 in addition to the applicable IVR code which itself is dependent on the intended use or the field of application of the software. In case software is incorporated in a device, used by the device or controls the device the code IVS 1010 is relevant. The IVDR requires the definition of specific qualification criteria for personnel allocated to the assessment of software (see IVDR Annex VII, Section 3.2.2, 6th indent).
The same principle applies to control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes where the code IVS 1007 should be attributed in addition to the applicable IVR code which itself is dependent on the intended use of the device. Note: The codes IVR 0701 and 0702 are only appropriate for controls without a quantitative or qualitative assigned value, i.e. no other IVR code higher in the list of IVR codes can be selected.
Code IVS 1008 (instruments, equipment, systems or apparatus) should be used if the IVD contains, is part of or is integrated into instruments, equipment, systems or apparatus. Note: The code IVR 0802 only applies in case of separate sterile instruments of class A intended by the manufacturer specifically to be used for in vitro diagnostic procedures.
Example: A blood glucose meter: An apparatus used for self-patient testing that contains an incorporated software to measure the glucose levels in the bloodstream will need to be assigned to the following IVS codes:
1) IVS 1002 – Devices intended to be used for self-testing, because it is to be used directly by the end user,
2) IVS 1008 – Instruments, equipment, systems or apparatus, because it is an apparatus in itself,
3) IVS 1010 – Devices incorporating software/utilising software/controlled by software, because it contains software.
3.3 IVT codes
IVT codes relate to the technologies that are used in the manufacturing and making available of the devices. IVT codes are most relevant for the allocation of site auditors.
Assignment of IVT codes should be done taking into consideration the production of the device itself, in addition to critical upstream production steps. This means that, even though many codes could be applicable when taking into consideration the technologies/processes involved in the entire supply chain, related to manufacture, of a medical device, only those for the critical technologies/production steps should be considered.
Example: An Immunoassay where the manufacturing involves antibody production, purification and immobilisation in a clean room/controlled environment should be assigned to at least the following IVT codes:
1) IVT 2005 – In vitro diagnostic devices manufactured using biotechnology and
2) IVT 2008 – In vitro diagnostic devices manufactured in clean rooms and associated controlled environments.
Note that, despite the fact that the manufacturer itself may not physically manufacture all parts of the device, the IVT codes concerning the manufacturing steps are assigned to the device since they are relevant when auditing suppliers / subcontractors.
3.4 IVP codes
IVP codes relate to the knowledge in examination procedures for the purpose of product verification. IVP codes are primarily used for the allocation of product reviewers.
Example 1: Microorganism identification using latex agglutination beads to detect specific microorganism antigens. IVP 3001: In vitro diagnostic devices which require knowledge regarding agglutination tests
Example 2: Immune cell phenotyping (e.g. to determine acute myeloid leukaemia) by flow cytometry. IVP 3006: In vitro diagnostic devices which require knowledge regarding flow cytometry
Example 3: Electrolyte quantification using ion-selective electrodes. IVP 3012: In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry
Example 4: Microorganism identification using mass spectrometry IVP 3012: In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry
Example 5: Colorimetric assay for the quantification of creatinine.
1) IVP 3002: In vitro diagnostic devices which require knowledge regarding biochemistry and
2) IVP 3013: In vitro diagnostic devices which require knowledge regarding spectroscopy
3.5 IVD codes
IVD codes relate to the knowledge in laboratory and clinical disciplines for the purpose of the product verification. IVD codes are relevant for the allocation of product reviewers.
The IVD codes listed in Commission Implementing Regulation 2017/2185 (IVD 4001 to 4012) refer to laboratory and clinical disciplines like bacteriology, clinical chemistry/biochemistry or immunology which specifically deal with or use the IVD in question. In addition, it may be necessary to involve experts of other clinical disciplines not listed in Commission Implementing Regulation 2017/2185 in which a disease or disorder to be detected with the IVD in question is treated (clinical specialists, see also e.g. IVDR Annex IX, 4.4). This may be the case, for example, when a marker for a disease is newly established by a manufacturer and the relevance of this marker for the underlying disease has to be assessed. Examples of these clinical disciplines may be cardiology or oncology.
4 Competence description: conditions (including limitations)
Conditions should be established by the NB for individual codes in cases where the qualification of the staff authorised to a certain code is not sufficient to cover the entire spectrum of the devices within this code. The designating authority could also apply conditions to the NB’s designation where the NB does not have sufficient competence to cover a given code or could seek designation for conformity assessment of only certain devices within a code.
Conditions, including limitations, should be formulated in an unambiguous way. Furthermore, since the technical codes mirror the competence system of the NB, the conditions and limitations should concern device characteristics. The experience and competence of the NB may for example be limited due to the range of devices assessed under the IVDD. The limitations are applicable to all types of codes. Here, the focus is on examples of IVR codes as they serve as the basis of the technical documentation assessment.
Example 1: IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer. In cases where the experience is solely based on assessing devices for PSA, an appropriate condition could be including only PSA.
Example 2: IVR 0401: Devices intended to be used in screening/confirmation of congenital/inherited disorders. In cases where the experience is solely based on assessing devices for T21 risk, an appropriate condition could be including only devices for T21 risk.
Example 3: IVR 0505: Devices intended to be used to grow/isolate/identify and handle infectious agents. In cases where the full code cannot be covered due to lack of experience in, for example, growing and isolating viruses, a suitable condition could be either to:
- limit the scope to devices intended to identify infectious agents
- exclusion of devices intended for growing and isolating viruses.
Further examples of conditions are illustrated in the final column of the table below. Considerations of the conditions should be based on the demonstrated competence of the applicant body.
5 Specific clarifications linked to individual codes
| 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 | Devices covered (3) and Specific Considerations (4) | Examples of conditions |
|---|---|---|---|
| IVR 0101 | Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)] | ABO typing, cross matching and identifying antibodies against ABO antigens listed | |
| IVR 0102 | Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)] | Rhesus typing, cross matching and identifying antibodies against Rhesus antigens listed | |
| IVR 0103 | Devices intended to determine markers of the Kell system [Kel1 (K)] | Kell typing, cross matching and identifying antibodies against Kell antigens listed | |
| IVR 0104 | Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)] | Kidd typing, cross matching and identifying antibodies against Kidd antigens listed | |
| IVR 0105 | Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)] | Duffy typing, cross matching and identifying antibodies against Duffy antigens listed | |
| Other devices intended to be used for blood grouping | |||
| IVR 0106 | Other devices intended to be used for blood grouping | Devices intended for other blood groups [e.g. MNS, Lewis, Anti-human globulin (Coombs serum)] | |
| 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 | Devices for typing, cross matching, identifying antibodies against listed HLA markers, relevant software, genetic screening and HLA CDC cross matching | |
| IVR 0202 | Other devices intended to be used for tissue typing | Other devices for tissue typing, other HLA markers [e.g. HLA C, DPA1, DPB1, DQB1, Human Neutrophil Antigen (HNA)] | |
| 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 | Immunoassays for cancer associated antigens (CA 12-5, CA 15-3, CA 19-9, CEA, HE4, PSA) Faecal occult blood screening test (FOBT) and faecal immuno-chemical test (FIT) Image analysis algorithms related to detection and/or quantitation of cancer markers Device intended for BRCA1 genetic testing of tumour tissue to confirm a potential cause and clinical diagnosis for hereditary breast and ovarian cancer and for molecular genetic testing of at-risk family members | Limit only to PSA devices where the experience is solely based on assessing devices for PSA (see section 4) |
| IVR 0302 | Other devices intended to be used for markers of cancer and non-malignant tumours | Companion diagnostic device for detection of somatic mutations in codons 12, 13 and 61 of the KRAS gene in human colorectal cancer (CRC) tumour tissue for determining eligibility for cetuximab or panitumumab treatment, devices (monoclonal antibodies) intended for the characterisation of hematologic neoplasia | |
| Devices intended to be used for human genetic testing | |||
| IVR 0401 | Devices intended to be used in screening / confirmation of congenital / inherited disorders | Devices intended for prenatal screening for trisomy 13, 18, and 21; and related software Genetic test for mutations in NPC1 and NPC2 genes for diagnosis of Niemann–Pick disease, type C NGS test panel and related software for diagnosis of amyotrophic lateral sclerosis (ALS) | In cases where the experience is solely based on assessing devices for T21 risk, an appropriate condition could be including only devices for T21 risk (see section 4) |
| IVR 0402 | Devices intended to be used to predict genetic disease/disorder risk and prognosis | Genetic testing for Cystic Fibrosis carriers Genetic testing for Alzheimer’s and Parkinson’s predictors (risk score) Genetic testing for diabetes and cardiovascular disease prognosis (risk scores) Software for calculating polygenic risk scores | |
| IVR 0403 | Other devices intended to be used for human genetic testing | Whole exome sequencing for suspected genetic disorders where a specific genetic test is not available Pharmacogenomic testing for genes for CYP liver enzymes CYP2C9 and CYP2C19 | |
| 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 | TORCH diagnostic: Antibodies (IgG, IgM) against rubella, toxoplasma Gondii, cytomegalovirus, herpes simplex Exclusion of molecular biology based devices or antigen detection devices as they detect the transmissible agent itself and not the antibodies against it | |
| 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 | Detection of viruses, bacteria, parasites or non-conventional infectious agents (e.g. vCJD) Immunological (detection of Ab and/or Ag) and molecular biology assays | |
| IVR 0503 | Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents | Tests for any infectious agent (bacteria, fungi, parasites, mycobacteria, viruses) using all possible direct and indirect methods (e.g. immunological assays, molecular biology assays, staining, histological assays) | |
| 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 | NAT for measuring viral load for HIV, measurement of tetanus Ab (protective level against tetanus) Including antigenic assays if they are quantitative Devices used to identify and enumerate TBNK cells (CD4) for monitoring some forms of immune deficiency and autoimmune disease and to monitor HIV individuals | |
| IVR 0505 | Devices intended to be used to grow / isolate / identify and handle infectious agents | Agar plate, liquid culture media, preservation media, minimal inhibition concentration (MIC) tests | A suitable condition could be either to: limit the scope to devices intended to identify infectious agents, exclusion of devices intended for growing and isolating viruses (see section 4). |
| IVR 0506 | Other devices intended to be used to determine markers of infections / immune status | Non-specific markers of sepsis (e.g. C-reactive protein, procalcitonin) | |
| Devices intended to be used for a specific disease | |||
| IVR 0601 | Devices intended to be used for screening / confirmation of specific disorders / impairments | Devices for exploration of kidney disorder or liver injury | |
| IVR 0602 | Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease | Measurement of clotting factors for specific diseases (e.g. von Willebrand factor, factor VIII for haemophilia A), haemoglobin A1c for diabetes monitoring | |
| IVR 0603 | Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances | IgE specific immunoassays, IgA anti-transglutaminase (coeliac disease) | |
| IVR 0604 | Other devices intended to be used for a specific disease | Other devices not falling into the codes above | |
| 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 | Medicinal product, or poison toxic products measurement or detection in blood (e.g lithium, warfarin, valproïc acid) or in urine (e.g. benzodiazepin) | |
| IVR 0606 | Devices intended to be used for non-infectious disease staging | Cholesterol, hormone measurement (estradiol progesterone, TSH, aldosterone) | |
| IVR 0607 | Devices intended to be used for detection of pregnancy or fertility testing | HCG, LH, estradiol (depending of the intended use) | |
| IVR 0608 | Devices intended to be used for screening, determination or monitoring of physiological markers | Urine or blood markers: magnesium, potassium, coagulation rate, INR, partial thromboplastin time (PTT), platelet count, platelet | |
| IVR 0609 | Other devices intended to be used to define or monitor physiological status and therapeutic measures | Other devices not falling into the codes above | |
| Controls without a quantitative or qualitative assigned value | |||
| IVR 0701 | Devices which are controls without a quantitative assigned value | Any IVD controls that are qualitative (e.g. control materials for detection of pathogens) | |
| IVR 0702 | Devices which are controls without a qualitative assigned value | Any IVD controls that do not fall under IVR 0701 (e.g. QC material as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection) A DNA or RNA probe supplied for use as a non-assay specific normal control for in situ hybridisation (ISH) | |
| 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 | Products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination (e.g. kits for isolation and purification of nucleic acids from human specimens, sterile buffer solutions, lysing solutions and diluents specified for use with an IVD) | |
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 | Sterile instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures | |
IVR 0803 | Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 | Specimen receptacles for e.g. blood, urine |
| IVS CODE | In vitro diagnostic devices with specific characteristics | Devices covered and Specific Considerations | Examples of conditions |
|---|---|---|---|
IVS 1001 | Devices intended to be used for near-patient testing | Troponin tests used in emergency room, blood glucose meter, blood grouping devices used for pre-transfusion control | |
| IVS 1002 | Devices intended to be used for self-testing | Pregnancy and fertility self-tests, HIV self-test, blood glucose meters | |
| IVS 1003 | Devices intended to be used as companion diagnostics | A companion diagnostic device provides information that is essential for the safe and effective use of a corresponding therapeutic product (e.g. used for the selection of therapeutic products, used for the treatment of cancers, for determination of hypersensitivity to anti-retroviral drugs) | |
IVS 1004 | Devices manufactured utilising tissues or cells of human origin, or their derivatives | Red blood cells as control for blood grouping | |
IVS 1005 | Devices in sterile condition | Blood or pathogens collection tubes and handling devices for pathogens (HPV collection tube) | |
IVS 1006 | Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746) | Calibrators sold separately from the measurement device (calibrators for blood glucose meters) | |
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) | Multi-analyte controls (anti-HIV, anti-HTLV, anti-HBc, anti-HCV, anti-CMV anti-treponema pallidum, and HBsAg), single analyte control (Factor II or Factor V positive control for NAT assays) | |
| IVS 1008 | Instruments, equipment, systems or apparatus | IVD analysers | |
| IVS 1009 | Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures | Software for sickle cell disease screening in newborns, software for hepatic fibrosis determination | |
IVS 1010 | Devices incorporating software / utilising software / controlled by software | Blood glucose meter |
| IVT CODE | In vitro diagnostic devices for which specific technologies are used | Examples of device manufacturing technologies |
|---|---|---|
IVT 2001 | In vitro diagnostic devices manufactured using metal processing | Stainless steel balls of grinding tubes, analyser with metal parts |
IVT 2002 | In vitro diagnostic devices manufactured using plastic processing | Plastic cassettes of rapid tests, plastic tubes for blood collection |
| IVT 2003 | In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics) | Glass tubes for blood collection or containing grow media |
| IVT 2004 | In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) | Weaving, knitting, printing |
| IVT 2005 | In vitro diagnostic devices manufactured using biotechnology | Antibody or other protein production and purification technologies |
| IVT 2006 | In vitro diagnostic devices manufactured using chemical processing | Manufacturing of reagents, chemical labelling |
| IVT 2007 | In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals | Production, handling and incorporation into an IVD of substances which, if used separately, can be considered to be a medicinal product |
| IVT 2008 | In vitro diagnostic devices manufactured in clean rooms and associated controlled environments | Aseptic filling of culture media |
| IVT 2009 | In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin | Handling, dissection, storage, processing, inactivation and sterilisation of human and animal tissues, sourcing |
| IVT 2010 | In vitro diagnostic devices manufactured using electronic components including communication devices | Software related to trisomy risk/PSA/blood glucose/pregnancy/ovulation |
| IVT 2011 | In vitro diagnostic devices which require packaging, including labelling | IVDs in sterile condition, packaging for light sensitive reagents |
IVP CODE | In vitro diagnostic devices which require specific knowledge in examination procedures | Devices covered and specific conditions | Examples of conditions |
|---|---|---|---|
IVP 3001 | In vitro diagnostic devices which require knowledge regarding agglutination tests | Microorganism identification, blood typing including latex agglutination | |
IVP 3002 | In vitro diagnostic devices which require knowledge regarding biochemistry | Creatinine, lactate | |
IVP 3003 | In vitro diagnostic devices which require knowledge regarding chromatography | Vitamin D analysed by HPLC, therapeutic drug monitoring by LC-MS/MS | |
IVP 3004 | In vitro diagnostic devices which require knowledge regarding chromosomal analysis | Chromosome staining, FISH (in combination with microscopy), chromosome painting, comparative genetic hybridisation | |
IVP 3005 | In vitro diagnostic devices which require knowledge regarding coagulometry | PT/INR | |
IVP 3006 | In vitro diagnostic devices which require knowledge regarding flow cytometry | Immunophenotyping by flow cytometry | |
IVP 3007 | In vitro diagnostic devices which require knowledge regarding immunoassays | ELISA, LFIA | |
IVP 3008 | In vitro diagnostic devices which require knowledge regarding lysis based testing | Euglobulin lysis | |
IVP 3009 | In vitro diagnostic devices which require knowledge regarding measurement of radioactivity | Radioimmunoassays | |
IVP 3010 | In vitro diagnostic devices which require knowledge regarding microscopy | Sediment analysis of urine, cell staining | |
IVP 3011 | In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS) | Huntington’s, BRCA1/2 | Limited when lack of NGS knowledge |
IVP 3012 | In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry | Electrolytes, glucose detection using electrochemical methods, mass spectrometry | |
IVP 3013 | In vitro diagnostic devices which require knowledge regarding spectroscopy | Absorption, fluorescence, scattering | |
IVP 3014 | In vitro diagnostic devices which require knowledge regarding tests of cell function | Lymphocyte function |
IVD CODE | In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification | Devices covered and specific conditions | Examples of conditions |
|---|---|---|---|
IVD 4001 | In vitro diagnostic devices which require knowledge regarding bacteriology | Culture medias, devices for identification, detection or measurement of bacteria | |
IVD 4002 | In vitro diagnostic devices which require knowledge regarding clinical chemistry / biochemistry | Non-automated devices and clinical chemistry analysers (single or multi- parameters) | |
IVD 4003 | In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses) | CJD, vCJD and other devices for non-conventional organism detection if available | |
IVD 4004 | In vitro diagnostic devices which require knowledge regarding genetics | Devices using nucleic acid-based technologies (NAT) such as PCR, RT- PCR, sequencing, LAMP and DNA/RNA microarrays, microRNA analysis, clinical epigenetics methods | |
| IVD 4005 | In vitro diagnostic devices which require knowledge regarding haematology / haemostasis, including coagulation disorders | Cell counts, haemoglobin, PT/INR, Factor V | |
IVD 4006 | In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics | Blood and tissue typing/compatibility, autoimmune conditions | |
IVD 4007 | In vitro diagnostic devices which require knowledge regarding immunohistochemistry / histology | Synaptophysin staining for diagnosis of neuroendocrine neoplasms, ICH or FISH for HER2 in breast cancer diagnostics | |
| IVD 4008 | In vitro diagnostic devices which require knowledge regarding immunology | Anti-dsDNA, anti-Sm and ANA antibodies, vaccine antibody test and antibody deficiency tests | |
IVD 4009 | In vitro diagnostic devices which require knowledge regarding molecular biology / diagnostics | Devices using nucleic acid-based technologies (NAT) such as PCR, RT-PCR, sequencing, genotyping, LAMP and DNA/RNA microarrays, microRNA analysis, clinical epigenetics methods | |
IVD 4010 | In vitro diagnostic devices which require knowledge regarding mycology | Assays for fungal infections | |
IVD 4011 | In vitro diagnostic devices which require knowledge regarding parasitology | Assays for parasitic infections | |
IVD 4012 | In vitro diagnostic devices which require knowledge regarding virology | Assays for viral infections and measurement of viral titers |
Footnotes
(1): The use of the codes in the sampling of technical documentation can be found in MDCG 2019-13: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B/Class C devices for the assessment of the technical documentation.
(2): Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
(3): The devices included in this column are only some examples of the devices covered in the relevant code. This column is not intended to provide an exhaustive list of devices included in each code. The intended purpose of each device needs to be carefully considered in the application of the codes.
(4): The assessment should also consider Section 5.1 of Annex IX as well as validation of SSP acc. Article 29.