Updated July 2026
MDR harmonised standards are European standards developed at the request of the European Commission to support Regulation (EU) 2017/745 on medical devices.
This guide explains, for informational purposes, what harmonised standards are, what role they may have in the context of the MDR, and where to consult the updated official list published by the European Commission.
In this guide
- What are MDR harmonised standards?
- Presumption of conformity and voluntary use
- Harmonised standards and MDR common specifications
- Where to find the official list of MDR harmonised standards
- How to read the European Commission list
- Harmonised standards, manufacturers and notified bodies
- Why this guide does not provide a complete list of MDR harmonised standards
- Why this guide does not indicate which standards apply to a device
What are MDR harmonised standards?
Harmonised standards are European standards developed by European standardisation organisations, such as CEN and CENELEC, on the basis of a standardisation request from the European Commission.
In the medical device sector, harmonised standards may cover very different topics, such as quality management, risk management, sterilisation, biocompatibility, symbols, information supplied by the manufacturer, electrical devices, clinical investigations, packaging and other technical areas.
In the context of the MDR, harmonised standards may be used as a technical reference to support the demonstration of conformity with certain requirements of the Regulation.
Not all technical standards applicable to medical devices are necessarily harmonised standards for the purposes of the MDR. Some non-harmonised standards, international standards or more recent versions of standards not yet published in the Official Journal of the European Union may still be relevant to understand the technical and scientific state of the art.
For this reason, the publication of the reference of the standard in the Official Journal of the European Union and the scope of the requirements covered by the standard are relevant elements for distinguishing MDR harmonised standards from other technical standards.
Presumption of conformity and voluntary use
The use of harmonised standards is voluntary. However, 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 to which the standard refers. This means that the harmonised standard may help demonstrate conformity with the requirements covered by the standard itself.
The presumption of conformity only concerns the requirements, or parts of requirements, covered by the relevant harmonised standard. Any Z annexes of the standard may help understand the link between the clauses of the standard itself and the requirements of the applicable European legislation.
The device, its intended purpose, its characteristics and the other applicable requirements of the MDR therefore remain relevant.
Harmonised standards and MDR common specifications
Harmonised standards should not be confused with the common specifications provided for by the MDR, which have a distinct function and are adopted by the European Commission in the cases provided for by the Regulation.
Common specifications may be adopted, for example, where no harmonised standards exist, where the relevant harmonised standards are not sufficient, or where there is a need to address aspects related to public health.
Where to find the official list of MDR harmonised standards
The official list of MDR harmonised standards is available on the European Commission pages dedicated to harmonised standards for medical devices.
European Commission publishes the references of harmonised standards in the Official Journal of the European Union and makes available lists and consultation pages linked to the applicable implementing decisions.
The European Commission page refers to the publications in the Official Journal of the European Union and may also include summary or consolidated lists. These lists are useful for consultation, but they do not produce legal effects on their own.
For Regulation (EU) 2017/745, the main reference is the European Commission page on harmonised standards for medical devices.
How to read the European Commission list
The list of MDR harmonised standards does not only include the number and title of the standard.
Depending on the format consulted, it may include information such as:
- reference Regulation;
- European standardisation organisation, such as CEN or CENELEC;
- reference and title of the standard;
- start date of legal effect;
- reference to publication in the Official Journal of the European Union;
- reference to the publication decision;
- possible end date of legal effect;
- possible references relating to withdrawal.
These elements are important because a standard may be updated, amended, replaced or withdrawn over time.
For this reason, the number of the standard alone does not necessarily describe all relevant information. The official list may also include the version, the date of legal effect and any publication, withdrawal or limitation references.
Harmonised standards, manufacturers and notified bodies
Harmonised standards may be relevant in the context of technical documentation and conformity assessment. The manufacturer may refer to harmonised standards to support certain parts of the demonstration of conformity with the applicable requirements.
When a notified body is involved, harmonised standards may be considered as part of the assessment of the technical documentation, the quality management system or other relevant aspects of the conformity assessment procedure.
The relevance of a standard depends on the device, its intended purpose, its technical characteristics and the applicable requirements of the MDR. The role of standards must therefore be assessed in the context of the device and of the requirements that are intended to be covered.
Why this guide does not provide a complete list of MDR harmonised standards
This guide does not provide a complete list of MDR harmonised standards.
This is intentional: the official list may be updated over time, and the most reliable reference remains the European Commission page dedicated to harmonised standards.
Providing a static list on this page would increase the risk of giving information that is outdated, incomplete or not aligned with the latest publications in the Official Journal of the European Union.
For this reason, this guide explains the role of harmonised standards in the context of the MDR and refers to the official sources for consulting the updated references.
Why this guide does not indicate which standards apply to a device
This guide does not indicate which harmonised standards apply to specific medical devices.
Identifying the relevant standards depends on elements such as the intended purpose of the device, the risk class, the technical characteristics, the materials, the operating principle, the manufacturing process, the sterilisation method, the packaging, the information supplied by the manufacturer and the applicable requirements of the MDR.
For this reason, this page is descriptive in nature and refers to the official texts, the updated European Commission lists and the 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 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 — Harmonised standards for medical devices and in vitro diagnostic medical devices
- European Commission — Harmonised standards for medical devices
- Official Journal of the European Union
- MDCG 2021-5 rev.1 — Guidance on standardisation for medical devices
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Related resources
- What is the MDR?
- MDR Notified Bodies
- MDR Classification Rules
- MDR Codes
- MDR Post-Market Surveillance
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