Harmonised Standards

Simplified Access to EU Harmonised Standards

Harmonised standards are the backbone of the Single European Market, ensuring safety, interoperability, and regulatory compliance across industries. As highlighted in the EU Strategy on Standardisation: “Standards are at the core of the EU single market.” Over the past 30 years, more than 3,600 harmonised standards have been introduced, enabling businesses to comply with EU legislation while enhancing consumer safety and environmental protection.

For Simplified Access to EU Harmonised Standards, Genorma.com provides a centralised platform offering up-to-date listings of harmonised standards, making it easy for businesses and authorities to quickly find the relevant standards.

Why Harmonised Standards Matter

Harmonised standards are among the most widely adopted in Europe. A prime example is the globally recognised Quality Management System standard (EN ISO 9001), implemented by millions of companies worldwide and certified by over one million organizations. These standards play a crucial role in ensuring product safety, environmental sustainability, and regulatory alignment across various sectors, including public procurement and market surveillance.

What Defines a Harmonised Standard?

Under Regulation (EU) 1025/2012, a harmonised standard is a European standard developed in response to a request from the European Commission. These standards facilitate compliance with Union harmonisation legislation, including New Legislative Framework Directives and Regulations. However, not all harmonised standards automatically provide a presumption of conformity with EU laws—only those cited in the Official Journal of the European Union (OJEU) hold this legal status.

Identifying Standards That Confer Presumption of Conformity

A European standard provides presumption of conformity only if:

It is developed as part of a standardisation request linked to a New Legislative Framework Directive or Regulation.

It is officially cited in the OJEU to support the application of the relevant legislation.

To easily determine if a standard is harmonised and whether it grants presumption of conformity, visit Genorma.com—a centralised platform offering up-to-date harmonised standard listings.

Some examples of a series of product-specific harmonised standards

EN 60335 Series - Household and similar electrical appliances - Safety, harmonised under the Low Voltage Directive (LVD - Directive 2014/35/EU) and/or the Machinery Safety Directive (Directive 2006/42/EC on Machinery)
EN 71 Series - Safety of Toys, harmonised under the Toys Safety Directive (Directive 2009/48/EC on the Safety of Toys)
EN 81 Series - Safety rules for the construction and installation of lifts and service lifts, harmonised under the Lifts Directive
EN 13630 Series- Explosives for civil uses (Directive 2014/28/EU for explosives for civil uses)
EN 16910 Series - Railway applications - Rolling stock (Directive 2008/57/EC on the interoperability of the rail system)
EN 1093 Series - Safety of machinery - Evaluation of the emission of airborne hazardous substances (Directive 2006/42/EC on Machinery)
EN 60204 Series - Safety of machinery - electrotechnical - (Directive 2006/42/EC on Machinery)
EN 60598 Series - Luminaires, harmonised under both the LVD (Directive 2014/35/EU for electrical equipment designed for use within certain voltage limits - Low Voltage Directive)
EN 60601 Series, harmonised under the Medical Devices Regulation (Regulation 2017/745 on medical devices)
EN 62368 Series - Audio/video, information and communication technology equipment, harmonised under both the LVD (Directive 2014/35/EU for electrical equipment designed for use within certain voltage limits - Low Voltage Directive) and the Radio Equipment Directive or RED (Directive 2014/53/EU on radio equipment)

Accreditation Harmonised Standards

As we indicated above, some famous management system standards are, in fact, harmonised standards as well. This is the case for standards such as ISO 9001, ISO 14001, and other management system standards.

In addition, many standards are used to establish or assess the requirements for the competence of conformity assessment bodies (testing, calibration, inspection and certification) such as:

EN ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories
EN ISO/IEC 17065:2012 - Conformity assessment - Requirements for bodies certifying products, processes and services
EN ISO/IEC 17011:2017 - Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies
EN ISO/IEC 17020:2012 - Conformity assessment - Requirements for the operation of various types of bodies performing inspection
EN ISO/IEC 17021-1:2015 - Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
EN ISO/IEC 17024:2012 - Conformity assessment - General requirements for bodies operating certification of persons
EN ISO 14064-1:2019 - Greenhouse gases - Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals

Summary of references of Harmonised Standards in support of Regulation (EU) 2017/745 on Medical Devices - MDR

Summary of references to harmonised standards / consolidated list of harmonised standards under the Medical Devices Regulation (EU) 2017/745, find and download the harmonised standards for the MDR providing presumption of conformity

Summary of relevant Harmonised standards for electrical equipment designed for use within certain voltage limits and drafted in support of Directive 2014/35/EU

Relevant Harmonised standards for certain electrical equipment designed for use within certain voltage limits. European standards and IEC standards supporting the low voltage Directive

Summary of references in the Official Journal in support of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices

Find, obtain and download the harmonised standards / consolidated list of harmonised standards under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Summary of references of Harmonised standards under the Electromagnetic Compatibility Directive (EMC)

List of Harmonised standards supporting the application of the Electromagnetic Compatibility Directive (EMC Directive). European standards, harmonized standards, standards providing presumption of conformity

Summary of references of Harmonised Standards supporting the ATEX Directive 2014/34/EU relating to equipment and protective systems intended for use in potentially explosive atmospheres

Harmonised Standards, Harmonized Standards, European standards providing presumption of conformity

Summary of references to European Standards published in the Official Journal (as of 2022-01) in support of the General Product Safety Directive

European standards supporting the application of General Product Safety Directive EU standards EN standards providing presumption of safety; Outdoor furniture; furniture; gymnastic equipment; stationary training equipment; cycles; etc

Summary of references to Harmonised Standards under the Machinery Directive

List of Harmonised standards supporting the application of the Machinery Directive. European standards, harmonized standards, standards providing presumption of conformity

Status of standards supporting the application of General Product Safety Directive as of January 2022

Informative review of standards supporting GPSD that may have been updated by CEN or CENELEC. It includes standards providing presumption of safety and other standards that may be used for the assessment of the safety of a product under GPSD

New Harmonised Standards on Passanger boarding bridges and Aircraft fuelling equipment under the Machinery Directive

EN 12312-4 and EN 12312-5 New standards providing presumption of conformity for aircraft ground support equipment under Directive 2006/42/EC

New Harmonised Standards under the Machinery Directive for welding equipment and electrostatic coating material application equipment

The European Commission has published in the Official Journal of the EU the reference of new harmonised standards under Directive 2006/42/EC: EN 17942:2024, EN 50059:2025 and EN 50176:2025

New Harmonised Standard on Craft bakery and pastry depositors under the Machinery Directive

Reference to EN 17677:2024 published in the Official Journal of the European Union as new standard providing presumption of conformity under the Machinery Directive

Updated list of Harmonised Standards under the Machinery Directive for lifts

Lifts for the transport of goods only, Accessible goods only lifts, Special lifts for the transport of persons and goods, Vertical lifting platforms intended for use by persons with impaired mobility, Lifting appliances in wind turbines

Harmonised standards under the low voltage directive for lampholders, boxes, enclosures, toilet appliances and electric vehicle charging

Publication of references of LVD harmonised standards for Edison screw lampholders, boxes and enclosures for electrical accessories, stationary circulation pumps, toilet appliances and electric vehicle conductive charging system European Standards

Publication of references of Harmonised Standards for the In Vitro Diagnostics Medical Devices Regulation for for sterilization of medical devices - IVDMDR

10th of April 2025 Update: Find and Download the Harmonised Standards under the In Vitro Diagnostics Medical Devices Regulation (IVDMDR) Harmonized Standards MDR Standards providing presumption of conformity for sterilization of medical devices

Publication of references of Harmonised Standards for the MDR for medical gloves for single use, sterilization of medical devices and patient handling equipment

April 2025 Update : Download Harmonised Standards under the Medical Devices Regulation (MDR) Harmonized Standards MDR Standards presumption of conformity for medical gloves for single use, sterilization of medical devices and patient handling equipment

European harmonised standards and Commission Regulation 2024/1103 on ecodesign requiremments for local space heaters and separate related controls

European harmonised standards supporting COMMISSION REGULATION (EU) 2024/1103 of 18 April 2024 implementing Directive 2009/125/EC as regards ecodesign requirements for local space heaters and separate related controls

Summary of references to Harmonised standards under the Directive on Safety of Toys (Toys Safety Directive)

Toys safety; Harmonised standards; Harmonized standards; EN standards on Safety of Toys; EU Standards; CEN and CENELEC Harmonised standards for toys

Summary of references to Harmonised standards under the Pressure Equipment Directive

Harmonised standards under the PED; Pressure Equipment Directive EU standards; European standards providing presumption of conformity; CEN and ISO standards;