EU-IVDR classification criteria
IVDR Classification
Manufacturers of in vitro diagnostics (IVD) often have numerous questions regarding the IVDR classification criteria according to the In Vitro Diagnostic Regulation (IVDR). The IVDR classifies IVDs based on risk, use, and the intended purpose of the device.
The IVD Directive 98/79/EC specifies Notified Body involvement for only a few high-risk IVDs listed in Annex II, whereas the IVD Regulation introduces risk-based classification Class A (the lowest) to D (the highest risk class). Annex XIII describes important implementing rules as well as seven
classification rules this
is supported by guidance MDCG 2020-16 - Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, which includes examples for each rule.
The IVDR requires a notified body conformity assessment of all classes except class A, which is non-sterile. There are additional conformity assessment requirements for Companion Diagnostics which also require a consultation with a medicine product competent authority, and class D devices require pre- and most market testing by a a designated EU reference laboratory. This is a significant increase in third-party oversight; under the IVDD, 80% of products were self-declared by the manufacturer, and under the IVDR, >90% could require a Notified Body.
IVDR Classification | How is your IVD classified?
Understanding the criteria and rules for IVDR classification can be complex; this is a high-level summary. and manufacturers seek clarification and guidance on how their specific product fits within the classification scheme.
Class D
High Public Health Risk, High Personal Risk
Class D covers general life-threatening conditions and, more specifically, transmissible agents in blood and biological materials intended to be transplanted or re-administered into the body. These tests represent a high personal and high public health risk.
Examples include tests
- 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, e.g., Screening assays for HIV, Hepatitis B & C, Syphilis, etc.
- 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; Diagnostic assays for HIV, Hepatitis B & C, Haemorrhagic fever viruses, etc.
- Determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management. E.g., HIV, Hepatitis B (DNA) & C virus.
- Blood grouping for specific markers named in rule 2 - ABO system, Rhesus system, Kell system, Kidd system, Duffy system see MDCG 2020-16.
This significantly expands the list of high-risk devices beyond those listed in the IVDD.
Class C
Moderate Public Health Risk, High Personal Risk
Class C covers a diverse mix of high-risk IVD devices, which may present a moderate to high personal health risk but a lower public health risk. It
tends to include situations where the failure of a test could result in a life-threatening situation for the patient, fetus, or offspring.
Examples include testing for
infectious diseases that could result in a life-threatening situation and cancer tests, whether these are diagnostic, predictive, or prognostic, infectious disease/sexually transmitted infections, companion diagnostics, genetic testing, TORCH screening, congenital disorders, monitoring high-risk medicines/substances. Class C covers self-testing IVD devices, although there are some exceptions specifically listed that are in class B.
Class B
Low Public Health Risk, Moderate Personal Risk
Class B
is the default classification that takes in all IVD devices that are not covered specifically in any other classification
rules.
Clinical chemistry tests, thyroid function, and fertility assays, and some specific self-test IVDs like pregnancy tests, fertility tests, and cholesterol tests.
Class A
Low Public Health Risk, Low Personal Risk
Class A covers accessories, laboratory devices, instruments, and specimen receptacles. These are products for general lab use, accessories with no critical characteristics (not assay-specific), buffers, washes, culture media, histological stains if intended for the specific test, and instruments intended for IVD procedures.
If a device is provided sterile, then a Notified Body is required to review the sterilization and associated processes such as packaging and labeling.
Conformity Assessment changes
The IVDR requires that the conformity assessment process for
CE marking for the majority of IVDs will now necessitate the involvement of a Notified Body, as opposed to self-declaration by the manufacturer under the IVDD. Only Class A, nonsterile devices will remain self-certified.
To take advantage of the full extended transition period, a manufacturer must have an IVDR compliance QMS by 26 May 2025 and lodge an application by the appropriate deadline for their class. See the transitional arrangements for further details). Manufacturers must update implementation plans. Make sure you fully understand the requirements to use this additional time effectively.
Notified Body support
Quality Management System QMS
Manufacturers should be upgrading their Quality Management System (QMS). All devices must have a QMS that is compliant with the IVDR. All device classes (except Class A, non-sterile IVDs) will need to have their QMS and their Technical File or Design Dossier audited by a Notified Body.
ISO 13485 is the harmonised standard; if a Notified Body is required to audit the QMS as part of a conformity assessment, this will form the basis for the audit. It is important to remember that the IVDR has additional requirements beyond ISO 13485, so attention should be paid to the text of the Regulation in addition to the standard. This includes additional risk management requirements in GSPR 1-8 that go beyond ISO 14971.
QMS support
Expert advice IVDR classification
Understanding the classification criteria according to the In Vitro Diagnostic Regulation (IVDR) can be a challenging task for manufacturers of in vitro diagnostic (IVD) products.
Fortunately, our IVD consultants and regulatory experts can assist in this process by understanding and applying the IVDR classification criteria using practical, real-world experience gained by working at manufacturers or notified bodies. Do you want to know how to comply with regulatory requirements and how to get successful market access to your devices? Learn more about our IVDR services.
IVDR services