Updated July 2026
IVDR codes are a tool used to describe the scope of designation of notified bodies under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
This guide explains, for informational purposes, what they are, where they are defined and why they are relevant in the context of notified bodies.
IVDR codes should not be confused with device classification: the risk classes under the IVDR are A, B, C and D, while the codes relate to the technical areas and competences covered by the designation of a notified body.
In this guide
- What are IVDR codes?
- What are IVDR codes used for?
- Where are IVDR codes defined?
- Types of IVDR codes
- IVR codes
- IVS codes
- IVT codes
- IVP codes
- IVD codes
- IVDR codes and notified bodies
- Conditions and limitations in the scope of designation
- Why this guide does not provide a complete table of IVDR codes
- Why this guide does not assign codes to devices
What are IVDR codes?
IVDR codes describe types of in vitro diagnostic medical devices, specific characteristics, technologies, processes and knowledge areas that are relevant in the context of notified body designation.
Commission Implementing Regulation (EU) 2017/2185 establishes the list of codes and corresponding types of devices used to specify the scope of designation of notified bodies in the in vitro diagnostic medical device sector under Regulation (EU) 2017/746.
In other words, they help specify the technical areas covered by the designation and the competences relevant for certain conformity assessment activities.
What are IVDR codes used for?
IVDR codes are mainly used by designating authorities to define the scope of designation of notified bodies.
MDCG 2021-14 also explains the role of IVDR codes in the context of notified body designation and the competences required for conformity assessment activities.
In the context of conformity assessment, the codes may therefore be relevant to describe:
- the scope of designation of a notified body;
- the qualifications of the personnel involved;
- the competences required for specific types of in vitro diagnostic medical devices;
- the allocation of resources in assessment activities.
Where are IVDR codes defined?
IVDR codes are defined in Commission Implementing Regulation (EU) 2017/2185, which contains the lists used to specify the scope of designation of notified bodies.
In particular, Annex II of Commission Implementing Regulation (EU) 2017/2185 contains the list of codes for in vitro diagnostic medical devices under Regulation (EU) 2017/746.
An important document for interpreting them is MDCG 2021-14 — Explanatory note on IVDR codes.
MDCG 2021-14 explains the different levels of IVDR codes and their use. The document also clarifies that MDCG guidance documents are not legally binding and that only the Court of Justice of the European Union can provide binding interpretations of Union law.
Types of IVDR codes
IVDR codes are organised into different categories. The main ones are:
- IVR codes;
- IVS codes;
- IVT codes;
- IVP codes;
- IVD codes.
These categories do not all have the same function. Some describe the intended purpose or type of device, while others refer to specific characteristics, technologies, processes or relevant laboratory and clinical knowledge areas.
IVR codes
IVR codes reflect the design and intended purpose of the in vitro diagnostic medical device.
In Commission Implementing Regulation (EU) 2017/2185, IVR codes include different categories of devices, for example devices intended to be used for blood grouping, tissue typing, tumour markers, human genetic testing, markers of infections or immune status, non-infectious diseases, controls without assigned value and class A devices in sterile condition.
These codes are particularly relevant for describing the type of device and the technical areas covered by the designation.
IVS codes
IVS codes are horizontal codes and describe specific characteristics of in vitro diagnostic medical devices.
They may relate, for example, to devices for near-patient testing, self-testing, companion diagnostics, devices in sterile condition, calibrators, control materials, instruments, equipment, systems or software.
Unlike IVR codes, multiple IVS codes may be relevant for the same device, depending on the applicable characteristics.
IVT codes
IVT codes describe technologies or processes used in the manufacture or making available of in vitro diagnostic medical devices.
They may relate, for example, to metal processing, plastic processing, mineral or non-mineral materials, biotechnology, chemical processes, clean room production, materials of human, animal or microbial origin, electronic components, communication, packaging or labelling.
These codes are mainly relevant for describing competences relating to specific technologies or processes.
IVP codes
IVP codes relate to in vitro diagnostic medical devices that require specific knowledge of examination procedures for the purpose of product verification.
They may relate, for example, to agglutination, biochemistry, chromatography, chromosomal analysis, coagulometry, flow cytometry, immunoassay, microscopy, molecular testing, spectroscopy or cell function tests.
These codes help describe technical and methodological knowledge relevant to certain examination procedures.
IVD codes
IVD codes relate to in vitro diagnostic medical devices that require specific knowledge in laboratory and clinical disciplines for the purpose of product verification.
They may relate, for example, to bacteriology, clinical chemistry/biochemistry, detection of transmissible agents, genetics, haematology/haemostasis, histocompatibility and immunogenetics, immunohistochemistry/histology, immunology, molecular biology/diagnostics, mycology, parasitology or virology.
These codes describe specialist knowledge areas that may be relevant in the context of the assessment of in vitro diagnostic medical devices.
IVDR codes and notified bodies
IVDR codes are closely connected to the scope of designation of notified bodies.
When consulting the designation of a notified body, the codes may indicate the technical areas, types of devices, characteristics, technologies, procedures or disciplines for which the body is designated.
For this reason, IVDR codes are connected to the topic of notified bodies, but they do not replace the official information provided in applicable sources, such as NANDO and designation documents.
Conditions and limitations in the scope of designation
MDCG 2021-14 explains that the scope of designation of a notified body may include conditions or limitations associated with certain codes, for example when the designation does not cover the entire scope associated with a specific code.
These conditions help clarify the actual scope of the designation and may indicate inclusions or exclusions relating to specific types of devices, technical characteristics, technologies, procedures or disciplines.
Why this guide does not provide a complete table of IVDR codes
This guide does not provide a complete table of IVDR codes.
This choice is intentional: the complete list of codes is available in Commission Implementing Regulation (EU) 2017/2185, while MDCG 2021-14 provides explanatory guidance on their use.
Official sources remain the main reference for consulting the codes, the corresponding types of devices and the applicable indications.
For this reason, this guide only explains the IVDR code system and refers back to the official sources.
Why this guide does not assign codes to devices
The association between codes and devices depends on elements such as the characteristics of the device, its intended purpose, the technologies involved, the manufacturing processes, the examination procedures, the relevant disciplines and the context of the conformity assessment procedure.
For this reason, this page is descriptive in nature and refers to the official texts and reference documents.
Informational note
This guide is published for informational purposes only and does not constitute regulatory, legal, technical or professional advice.
The information is based on publicly available sources and was checked as of the publication or last update date of this page. It may therefore not reflect subsequent changes or developments.
For assessments relating to specific cases, it is necessary to refer to the official texts, the updated documentation of the competent authorities and, where appropriate, qualified professionals.
Official sources
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- Commission Implementing Regulation (EU) 2017/2185
- MDCG 2021-14 — Explanatory note on IVDR codes
- NANDO — New Approach Notified and Designated Organisations
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Related resources
- What is the IVDR?
- IVDR Notified Bodies
- IVDR Classification Rules
- IVDR Harmonised Standards
- IVDR Post-Market Surveillance
- UDI and Basic UDI-DI
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