What Are Harmonized Standards?
Harmonized standards are technical specifications developed by recognized European Standardization Organizations (ESOs), such as:
CEN (European Committee for Standardization)
CENELEC (European Committee for Electrotechnical Standardization)
ETSI (European Telecommunications Standards Institute)
These standards provide a presumption of conformity with relevant EU directives and regulations, helping manufacturers ensure their products meet safety, health, and environmental requirements.
Why Are Harmonized Standards Important?
✅ Simplifies Compliance – Products meeting harmonized standards automatically comply with applicable EU directives. ✅ Ensures Market Access – Essential for obtaining CE marking and selling products within the European Economic Area (EEA). ✅ Reduces Risk – Conforms to well-defined safety and performance criteria, minimizing liability concerns. ✅ Recognized by Authorities – Accepted by regulatory bodies for conformity assessments.
How Do Harmonized Standards Work?
The European Commission Publishes a List of Harmonized Standards
These are officially recognized in the Official Journal of the European Union (OJEU).
Manufacturers Use the Standards to Ensure Compliance
By following a harmonized standard, products gain presumption of conformity with relevant EU laws.
Products Are Tested According to the Standard
Compliance may require self-certification or third-party testing.
The Manufacturer Issues a Declaration of Conformity (DoC)
This document confirms the product meets the harmonized standard requirements.
Examples of Common Harmonized Standards
Directive/Regulation | Harmonized Standard Example |
Low Voltage Directive (2014/35/EU) | EN 60950-1 (Electrical Safety) |
EMC Directive (2014/30/EU) | EN 55032 (Electromagnetic Compatibility) |
Machinery Directive (2006/42/EC) | EN 12100 (Machine Safety) |
Medical Devices Regulation (MDR 2017/745) | EN ISO 14971 (Risk Management) |
Toy Safety Directive (2009/48/EC) | EN 71 Series (Toy Safety) |
For a full list of harmonized standards, visit the Official Journal of the EU (OJEU) or use compliance tools like Euverify.
How to Find and Apply the Right Harmonized Standard?
Identify the Applicable Directive – Determine which EU directive or regulation applies to your product.
Check the List of Harmonized Standards – Use the OJEU database or compliance platforms like Euverify.
Test Products According to the Standard – Ensure products meet the specific safety and technical requirements.
Issue a Declaration of Conformity (DoC) – State that the product complies with the relevant harmonized standards.
Harmonized Standards vs. Non-Harmonized Standards
Feature | Harmonized Standards | Non-Harmonized Standards |
Legal Status | Recognized under EU directives | General industry standards |
Market Acceptance | Required for CE marking | May not be sufficient for regulatory compliance |
Presumption of Conformity | Yes | No |
Enforcement | Mandatory in applicable categories | Voluntary, but recommended |