MDCG release new guidance on classification rules for In Vitro Diagnostic Devices
With the In Vitro Diagnostic Device Regulation (IVDR) date of application approaching, the Medical Device Coordination Group (MDCG) issued a new guidance to help manufacturers with their device’s classification. Diagnostics are divided in four classes (A, B, C and D) depending on their intended purpose and associated risk, A being the lowest and D the highest.
The conformity assessment route is highly dependent on classification, as certain requirements from the IVDR are directly linked to the class of the device. For example, a consultation with a national medicine agency or the European Medicines Agency is requested for the approval of companion diagnostics.
Therefore, it is of the highest importance for the manufacturer to clearly define the purpose of the device, in order to enable a clear attribution of the class. DDR ordered the several rules from the MDCG guidance in a table available below.
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|CLASSIFICATION||RULE||TYPE||EXAMPLES (non-exhaustive list)|
|CLASS D||Rule 1||Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration.||Devices typically falling under this rule are those that detect agents for which the EU has clearly harmonised the donor and donation testing requirements, as outlined in the relevant European directives.|
|CLASS D||Rule 1 second indent||Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a lifethreatening disease with a high or suspected high risk of propagation.||Devices intended for. Hepatitis B Virus, Hepatitis C Virus, Hepatitis D Virus, Haemorrhagic fever viruses...|
|CLASS D||Rule 1 third indent||Devices intended to be used for determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.||Devices intended to be used for determining the infectious load of: Hepatitis B Virus (DNA), Hepatitis C Virus, Human Immunodeficiency Virus.|
|CLASS D||Rule 2||Devices intended to be used for blood grouping , or to determine foeto-maternal blood group incompatibility1, or 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, when intended to determine any of the following markers:|
– ABO system [A (ABO1), B (ABO2), AB (ABO3)]
– Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
– Kell system [KEL1 (K)]
– Kidd system [JK1 (Jka), JK2 (Jkb)]
– Duffy system [FY1 (Fya), FY2 (Fyb)]
|- Device intended for molecular RhD blood group typing, targeting directly the RHD gene alleles that code for the RBC antigens, in blood donors and recipients.
- Anti-K from clone ID, Human IgM Antibody, Blood grouping reagent for transfusion purposes.
- Red blood cell kit with A1, A2, B and O cells used to detect naturally-occurring ABO blood group antibodies in patient and donor samples, in reverse grouping.
|CLASS C||Rule 2||Other devices intended to be used for blood grouping , or to determine foeto-maternal blood group incompatibility, or 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.||- Device intended for HLA typing by Sanger sequencing consisting of reagents for HLA-A, -B, -C, -DRB1, -DQB1 and DPB1, for transplantation purposes.
- Medical device software for high-resolution analysis of HLA sequencing data, for transplantation purposes.
|CLASS C||Rule 3 (a)||Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent.||Devices intended for the detection of: Chlamydia trachomatis, Haemophilus ducreyi, Herpes simplex virus 1&2, Human papilloma virus (HPV).|
|CLASS C||Rule 3 (b)||Devices intended for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation.||Devices intended for detecting the presence of: bacterial pathogens, fungal pathogens, viral pathogens, parasitic pathogen, prion agents.|
|CLASS C||Rule 3 (c)||Devices intended for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring.||Devices intended for detecting the presence of: bacterial pathogens, parasitic pathogens, viral pathogens.|
|CLASS C||Rule 3 (d)||Devices intended for pre-natal screening of women in order to determine their immune status towards transmissible agents.||Devices intended to determine for prenatal screening the immune status of women towards: Cytomegalovirus, Rubella virus, Toxoplasma gondii, Varicella zoster virus, Zika, Parvovirus B19.|
|CLASS C||Rule 3 (e)||Devices intended for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring.||Devices intended to determine:
- Salmonella typhi in faeces, for the assessment of the carrier-status of patients.
- Antibodies from lymphocyte secretions immunoassay intended for the detection of active Mycobacterium tuberculosis infection.
- Quantitative virus-specific NAT tests.
|CLASS C||Rule 3 (f)||Devices intended to be used as companion diagnostics.||‘Companion diagnostic’ is defined in Article 2(7) as a device which is essential for the safe and effective use of a corresponding medicinal product to:
a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
|CLASS C||Rule 3 (g)||Devices intended to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring.||This rule applies to devices where the information provided from the device is intended to be used for disease staging and where the patient management decision, being solely or principally based on an erroneous result, has the potential to result in a life-threatening situation.|
|CLASS C||Rule 3 (h)||Devices intended to be used in screening, diagnosis, or staging of cancer.||Devices that are intended to be used in screening, diagnosis, or staging of cancer, may have the following functions: screening, patient management, monitoring, diagnosis or aid to diagnosis, prognosis and prediction.|
|CLASS C||Rule 3 (i)||Devices intended for human genetic testing.||Genetic testing may include devices intended to detect :
- Chromosomal conditions e.g. trisomy 21, trisomy 18, XXX syndrome.
- Abnormalities in genes associated with thrombophilia e.g. genes which code for factor V and prothrombin.
- Hereditary cancer syndromes.
|CLASS C||Rule 3 (j)||Devices intended for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring.||Devices intended for monitoring:
- Cardiac marker for acute presenting patients: Troponin I, Troponin T, CKMB (when intended for monitoring cardiac muscle injury).
- Cortisol levels monitoring e.g. for patients with cortisol insufficiency.
- Lithium for patients being treated for bipolar disorders.
|CLASS C||Rule 3 (k)||Devices intended for management of patients suffering from a life-threatening disease or condition.||Devices intended for:
- Enumeration of CD4 T lymphocytes in HIV infected patients to initiate treatment and ascertain the anti-viral therapy response.
- Measurement of D-Dimers in patients with thrombotic disorders.
- Laboratory risk score calculator indicator for necrotising fasciitis in necrotising soft tissue infections.
|CLASS C||Rule 3 (l)||Devices intended for screening for congenital disorders in the embryo or foetus.||- Devices intended for screening of foetal aneuploidies (e.g. trisomy 13, trisomy 18 and trisomy 21).
- Reagents and medical device software evaluating the risk of foetal aneuploidies based on biochemical markers and other information.
- Genetic test for cystic fibrosis.
|CLASS C||Rule 3 (m)||Devices intended for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities.||Examples of devices intended for screening in new-born babies for congenital disorders:
- Biotinidase deficiency.
- Congenital adrenal hyperplasia
|CLASS C||Rule 4 (a)||Devices intended for self-testing.||- Devices for self-testing of blood sugar.
- Self-testing devices for blood clotting.
|CLASS B||Rule 4 (a)||Devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine.|
|CLASS B||Rule 6||Devices not covered by all the other classification rules are classified as class B.||- Device intended to detect and measure magnesium to assess electrolyte / magnesium homeostasis.
- Test intended to detect and measure C-reactive protein or calprotectin to detect systemic inflammatory processes due to an active disease.
|CLASS B||Rule 7||Devices which are controls without a quantitative or qualitative assigned value.||- Unassigned control sera.
- Control materials used to verify the migration of immunochromatographic assays.
- Unassigned QC Material as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection.
|CLASS A||Rule 5 (a)||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.||- General microbiological culture media containing selecting agents, antimicrobial chromogenic agents, chemical indicators for colour differentiation.
- Solutions like cleaners, buffer solutions, lysing solutions, diluents specified for use with an IVD.
|CLASS A||Rule 5 (b)||Instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures.||- Enzyme immunoassay analyser, PCR thermocycler, sequencer for NGS applications, clinical chemistry analyser.
- Instrument for automated purification of nucleic acids and PCR set-up.
- Erythrocyte sedimentation rate analyser.
|CLASS A||Rule 5 (c)||Specimen receptacles.||Specimen containers or evacuated or non-evacuated tubes, empty or prefilled with a fixative solution or other general reagent to preserve the condition, stimulation, transport, storage and collection of biological specimens (e.g. cells, tissues specimens, urine, faeces) for the purpose of in vitro diagnostic examinations.|
|Classified in their own right||Rule 4 (b)||Devices intended for near-patient testing.||The classification of devices for near-patient testing follows the intended purpose of the device, as established by the manufacturer.|