Whereas the IVD Directive 98/79/EC specifies Notified Body involvement for only a few high risk IVDs listed in Annex VII, the IVD Regulation introduces risk-based classification Class A to D, based on IMDRFrules and similar to Health Canada and TGA classification rules.
The outcome is that the conformity assessment process for CE marking for the majority of IVDs will now necessitate involvement of a Notified Body, as opposed to self-declaration by the manufacturer under the IVDD.
The majority of IVDs currently self-certified will now require the services of a Notified Body in the conformity assessment process to ensure the safety and performances of IVDs placed on the EU market.
Under the IVDR, Devices are divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks!
Class D: High Public health and Personal risk i.e. Screening for transmissible agents and for high risk blood grouping for transfusion, transplantation, cell administration; life-threatening transmissible agents : Screening where possible high risk of propagation, and detection of infectious load where monitoring determines patient management e.g. Blood groups ABO, Rh, Kidd, Duffy, Kell; HIV1 and 2, HTLV I/II, Hep B and C, Chagas, screening blood for syphilis
Class C: Public health risk moderate – low; Personal risk low i.e. Testing for compatibility for transfusion, transplantation, cell administration, excluding high risk blood grouping; tests for Infectious disease / STI agents / cancer biomarkers / Companion diagnostics / genetic testing / TORCH screening / congenital disorders / monitoring high risk medicines/substances e.g. blood glucose / most self test IVDs.
Class B: Public health risk Low; Personal risk moderate to low i.e. clinical chemistry tests, some specific self-test IVDs – Class B is also the default ruling where no other Rule applies.
Class A: Public health and personal risk low, e.g. Specimen receptacles; products for general lab use, accessories with no critical characteristics, buffers, washes, culture media, histological stains if intended for specific test; instruments intended for IVD procedures
Devices intended to be used for the following purposes are classified as class D: — 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; — detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation; — 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 blood grouping, 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, are classified as class C, except 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)]; in which case they are classified as class D.
Devices are classified as class C if they are intended:
- for detecting the presence of, or exposure to, a sexually transmitted agent;
- for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;
- 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;
- for pre-natal screening of women in order to determine their immune status towards transmissible agents;
- 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;
- to be used as companion diagnostics;
- 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;
- to be used in screening, diagnosis, or staging of cancer;
- for human genetic testing;
- 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;
- for management of patients suffering from a life-threatening disease or condition;
- for screening for congenital disorders in the embryo or foetus;
- 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.
- Devices intended for self-testing are classified as class C, except for 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, which are classified as class B.
- Devices intended for near-patient testing are classified in their own right.
The following devices are classified as class 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;
- instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
- specimen receptacles.
Devices not covered by the above-mentioned classification rules are classified as class B.
Devices which are controls without a quantitative or qualitative assigned value are classified as class B.