Updated July 2026
The MDR, or Medical Device Regulation, is Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
This guide explains, for informational purposes, what the MDR regulates and introduces some useful concepts to help navigate the European regulatory framework for medical devices.
The MDR replaced Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.
As a European Union regulation, the MDR 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 MDR applies to
- Why the MDR was introduced
- MDR transitional period
- MDR and IVDR: main differences
- Key MDR concepts
- Classification of medical devices
- Conformity assessment and CE marking
- MDR Notified Bodies
- Harmonised standards and common specifications
- MDR Codes
- UDI and Basic UDI-DI
- MDR Post-Market Surveillance
- Other MDR topics
What the MDR applies to
The MDR lays down rules concerning the placing on the market, making available on the market and putting into service in the European Union of medical devices for human use and their accessories.
In general terms, the MDR applies to devices intended by the manufacturer to be used in humans for medical purposes, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, or diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
The MDR also regulates accessories for medical devices and certain categories of products without an intended medical purpose listed in Annex XVI, according to the conditions set out in the Regulation and the applicable common specifications.
In vitro diagnostic medical devices do not fall within the scope of the MDR. They are regulated by Regulation (EU) 2017/746, known as the IVDR.
Why the MDR was introduced
The MDR was introduced to strengthen and update the European regulatory framework for 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 medical device system.
Among the aspects strengthened by the MDR are, for example, clinical evaluation, post-market surveillance, vigilance, device traceability, the role of notified bodies and the obligations of economic operators.
MDR transitional period
The transition from the previous directives, in particular Directive 93/42/EEC and Directive 90/385/EEC, to the MDR was accompanied by transitional provisions, which were subsequently amended by the European legislator.
In general terms, these provisions set out specific timelines and conditions for certain categories of devices, with the aim of facilitating the transition to the new regulatory framework and helping to ensure the availability 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 MDR, to the regulations that amended it, including Regulation (EU) 2023/607, 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.
A medical device may be, for example, an instrument, apparatus, implant, software or other product intended for medical purposes in humans.
An in vitro diagnostic medical device is instead intended for the examination of specimens derived from the human body, such as blood or tissue, to provide diagnostic, physiological, pathological or predictive information.
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 MDR concepts
The MDR regulates several aspects of the life cycle of medical devices, including:
- device classification;
- conformity assessment;
- CE marking;
- general safety and performance requirements;
- technical documentation;
- clinical evaluation and clinical investigations;
- 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 medical devices
The MDR provides for the classification of medical devices into four risk classes:
- class I;
- class IIa;
- class IIb;
- class III.
Classification is carried out according to the rules set out in Annex VIII of the MDR 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: MDR Classification Rules →
Conformity assessment and CE marking
Before being placed on the market, a medical device must undergo a conformity assessment procedure.
Conformity assessment is intended to demonstrate that the device meets the applicable requirements of the MDR.
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.
MDR Notified Bodies
Notified bodies are conformity assessment bodies designated to carry out specific activities under the MDR.
Their involvement depends on the class of the device and the applicable conformity assessment procedure.
In general, devices belonging to higher risk classes require the involvement of a notified body, while for some class I devices the involvement may not be required or may be limited to specific aspects.
Learn more in the guide: MDR 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 MDR.
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 MDR.
Learn more in the guide: MDR Harmonised Standards →
MDR Codes
MDR 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.
MDR codes should not be confused with the risk classes of medical devices.
Learn more in the guide: MDR Codes →
UDI and Basic UDI-DI
The UDI system, or Unique Device Identification, is the unique device identification system provided for by the MDR to enable the identification and facilitate the traceability of 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 MDR 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 →
MDR Post-Market Surveillance
Post-market surveillance is one of the processes established by the MDR 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 clinical evaluation, risk management, technical documentation, instructions for use and, where applicable, the summary of safety and clinical 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 MDR context, the PMS system is also connected to PMCF, the post-market clinical follow-up.
Learn more in the guide: MDR Post-Market Surveillance →
Other MDR topics
In addition to the aspects introduced in this guide, the MDR regulates many other topics relevant to the life cycle of medical devices.
These include, for example, EUDAMED, vigilance, clinical evaluation, clinical investigations, technical documentation and, for devices for which it is required, the summary of safety and clinical performance.
These topics require dedicated explanations and will be covered in specific guides.
Why this guide does not interpret the MDR for specific cases
This guide does not interpret the MDR for specific cases and does not determine the obligations applicable to a specific device, manufacturer or economic operator.
The application of the MDR 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 verified as of the date of publication or the latest update of this page. It may therefore not reflect subsequent changes or developments.
For assessments relating to specific cases, reference should be made to the official texts, the latest documentation issued by the competent authorities and, where appropriate, qualified professionals.
Official sources
- Regulation (EU) 2017/745 on medical devices
- European Commission — Medical devices: new regulations
- European Commission — Medical Devices – Sector
- European Commission — EUDAMED
- MDCG — Guidance documents on MDR and IVDR
- Regulation (EU) 2023/607 on transitional provisions for certain medical devices and in vitro diagnostic medical devices
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Related resources
- MDR Notified Bodies
- MDR Codes
- MDR Classification Rules
- MDR Harmonised Standards
- MDR 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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