Updated July 2026
The IVDR is Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices.
This guide explains, for informational purposes, what the IVDR regulates and introduces some useful concepts to help navigate the European regulatory framework for in vitro diagnostic medical devices.
The IVDR replaced Directive 98/79/EC on in vitro diagnostic medical devices.
As a European Union regulation, the IVDR is directly applicable in the Member States, according to the provisions and timelines set out in the Regulation itself and in subsequent amendments.
In this guide
- What the IVDR applies to
- Why the IVDR was introduced
- IVDR transitional period
- MDR and IVDR: main differences
- Key IVDR concepts
- Classification of in vitro diagnostic medical devices
- Conformity assessment and CE marking
- IVDR Notified Bodies
- Harmonised standards and common specifications
- IVDR Codes
- UDI and Basic UDI-DI
- IVDR Post-Market Surveillance
- Other IVDR topics
What the IVDR applies to
IVDR lays down rules concerning the placing on the market, making available on the market and putting into service in the European Union of in vitro diagnostic medical devices for human use and their accessories.
The Regulation also lays down rules concerning the conduct of performance studies involving in vitro diagnostic medical devices and their accessories in the European Union.
The expression “in vitro” means that the examination is performed outside the human body, for example in a laboratory, on specimens taken from the human body.
In general terms, an in vitro diagnostic medical device is intended for the in vitro examination of specimens derived from the human body, including blood and tissue, to provide information relating, for example, to physiological or pathological processes, predispositions to medical conditions or diseases, compatibility with potential recipients, response or reactions to treatments, or the definition or monitoring of therapeutic measures.
Medical devices that are not in vitro diagnostic medical devices do not fall within the scope of the IVDR. They are regulated by Regulation (EU) 2017/745, known as the MDR.
Why the IVDR was introduced
The IVDR was introduced to strengthen and update the European regulatory framework for in vitro diagnostic medical devices.
The Regulation aims to ensure a high level of protection of health and safety, while also improving the transparency, traceability and functioning of the European system for in vitro diagnostic medical devices.
Among the aspects strengthened by the IVDR are, for example, risk-based classification, performance evaluation, performance studies, post-market surveillance, vigilance, the role of notified bodies and the obligations of economic operators.
IVDR transitional period
The transition from Directive 98/79/EC to the IVDR was accompanied by transitional provisions, which were subsequently amended by the European legislator.
In general terms, these provisions set out staggered timelines and specific conditions for certain categories of devices, with the aim of facilitating the transition to the new regulatory framework and helping to avoid shortages of devices on the market.
To assess the applicability of the transitional provisions to a specific case, it is necessary to refer to the updated text of the IVDR, to the regulations that amended it, including Regulation (EU) 2024/1860, and to the official guidance of the European Commission.
MDR and IVDR: main differences
MDR and IVDR are two distinct European regulations.
The MDR concerns medical devices, while the IVDR concerns in vitro diagnostic medical devices.
In general terms, the MDR concerns products intended for medical purposes in humans, while the IVDR concerns devices intended for the in vitro examination of specimens derived from the human body.
For this reason, although MDR and IVDR are part of the European regulatory framework for medical devices and in vitro diagnostic medical devices, they have distinct scopes, classification rules and specific requirements.
Key IVDR concepts
The IVDR regulates several aspects of the life cycle of in vitro diagnostic medical devices, including:
- device classification;
- conformity assessment;
- CE marking;
- general safety and performance requirements;
- technical documentation;
- performance evaluation and performance studies;
- post-market surveillance and vigilance;
- unique device identification and traceability;
- role of economic operators;
- notified bodies;
- harmonised standards and common specifications.
These topics are interconnected and must be considered in the context of the device, its intended purpose, its risk class and the applicable requirements.
Classification of in vitro diagnostic medical devices
The IVDR provides for the classification of in vitro diagnostic medical devices into four risk classes:
- class A;
- class B;
- class C;
- class D.
Classification is carried out according to the rules set out in Annex VIII of the IVDR and takes into account the intended purpose of the device and its inherent risks.
In general terms, the higher the risk class, the greater the level of control required in the conformity assessment process.
Learn more in the guide: IVDR Classification Rules →
Conformity assessment and CE marking
Before being placed on the market, an in vitro diagnostic medical device must undergo a conformity assessment procedure.
Conformity assessment is intended to demonstrate that the device meets the applicable requirements of the IVDR.
When the procedure is successfully completed, the device may bear the CE marking, according to the conditions set out in the Regulation.
The conformity assessment pathway depends on several elements, including the risk class of the device and the applicable procedure.
IVDR Notified Bodies
Notified bodies are conformity assessment bodies designated to carry out specific activities under the IVDR.
Their involvement depends on the class of the device and the applicable conformity assessment procedure.
Under the IVDR, devices belonging to classes B, C and D generally require the involvement of a notified body in the conformity assessment procedure.
Non-sterile class A devices normally do not require the involvement of a notified body, while for class A devices placed on the market in sterile condition the intervention of the notified body is limited to the aspects relating to sterility.
Learn more in the guide: IVDR Notified Bodies →
Harmonised standards and common specifications
Harmonised standards are European standards developed at the request of the European Commission and may support the demonstration of conformity with certain requirements of the IVDR.
When the reference of a harmonised standard is published in the Official Journal of the European Union, the use of that standard may confer a presumption of conformity with the requirements of the Regulation covered by the standard itself.
Common specifications are instead tools distinct from harmonised standards and may be adopted by the European Commission in the cases provided for by the IVDR.
Learn more in the guide: IVDR Harmonised Standards →
IVDR Codes
IVDR codes are used in the context of the designation and surveillance of notified bodies.
These codes help describe the scope of designation of a notified body, namely the technical areas and types of devices for which the body is designated.
IVDR codes should not be confused with the risk classes of in vitro diagnostic medical devices.
Learn more in the guide: IVDR Codes →
UDI and Basic UDI-DI
The UDI system, or Unique Device Identification, is the unique device identification system provided for by the IVDR to enable the identification and facilitate the traceability of in vitro diagnostic medical devices.
In general terms, the UDI consists of two elements: the UDI-DI, which identifies the device model, and the UDI-PI, which identifies the device production unit, for example through a lot number, serial number or other applicable information.
The Basic UDI-DI, or basic UDI-DI, has a different function. It is not the UDI placed on the label or packaging, but the main regulatory identifier of a device model or group of devices.
In the IVDR context, the UDI system is connected to traceability, device registration, the UDI database, EUDAMED, technical documentation and the EU declaration of conformity.
Learn more in the guide: UDI and Basic UDI-DI →
IVDR Post-Market Surveillance
Post-market surveillance is one of the processes established by the IVDR to monitor a device after it has been placed on the market or put into service.
In general terms, the PMS system enables the manufacturer to actively and systematically collect, record and analyse data on the quality, performance and safety of the device throughout its entire lifetime.
The data collected through post-market surveillance may contribute to updating the performance evaluation, risk management, technical documentation, instructions for use and, where applicable, the summary of safety and performance.
Depending on the class of the device, the results of post-market surveillance are documented through the PMS report or the PSUR. In the IVDR context, the PMS system is also connected to PMPF, the post-market performance follow-up.
Learn more in the guide: IVDR Post-Market Surveillance →
Other IVDR topics
In addition to the aspects introduced in this guide, the IVDR regulates many other topics relevant to the life cycle of in vitro diagnostic medical devices.
These include, for example, EUDAMED, vigilance, performance evaluation, performance studies, technical documentation and, for devices for which it is required, the summary of safety and performance.
These topics require dedicated explanations and will be covered in specific guides.
Why this guide does not interpret the IVDR for specific cases
This guide does not interpret the IVDR for specific cases and does not determine the obligations applicable to a specific device, manufacturer or economic operator.
The application of the IVDR depends on elements such as the intended purpose of the device, its classification, its technical characteristics, the role of the economic operator, the available documentation and the applicable regulatory context.
For this reason, this page is introductory in nature and refers to the official texts and thematic guides for further information.
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
- Regulation (EU) 2024/1860 on transitional provisions for certain in vitro diagnostic medical devices
- European Commission — In vitro diagnostics
- European Commission — Transitional provisions
- European Commission — Medical devices: new regulations
- European Commission — EUDAMED
- MDCG — Guidance documents on MDR and IVDR
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Related resources
- IVDR Codes
- IVDR Classification Rules
- IVDR Notified Bodies
- IVDR Harmonised Standards
- IVDR Post-Market Surveillance
- UDI and Basic UDI-DI
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© Simone Ronco. Unless otherwise stated, the editorial content of this guide is an original work.
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