Harmonised Standards (hEN) represent the intersection of technical engineering and European law. Unlike voluntary consensus standards, these documents are developed following a formal standardisation request (mandate) from the European Commission. By applying them, manufacturers trigger a legal “Presumption of Conformity,” significantly reducing the burden of proof required to affix the CE Mark. Below is a technical analysis of their legal function, application, and acquisition.
Definition & Legal Basis
A Harmonised Standard is a European Standard (EN) adopted by one of the three European Standardisation Organisations (CEN, CENELEC, or ETSI) under Regulation (EU) No 1025/2012.
The defining characteristic of a harmonised standard is its citation in the Official Journal of the European Union (OJEU). Once cited, the standard provides a technical solution that is legally presumed to meet the essential health and safety requirements of the corresponding EU Directive or Regulation.
Strategic Advantages for Manufacturers:
- ✅ Legal Security: Reverses the burden of proof; authorities must assume compliance unless proven otherwise.
- ✅ Simplified Conformity Assessment: Often eliminates the need for EC Type-Examination by a Notified Body (depending on the Directive).
- ✅ Technical Alignment: Ensures product interoperability across the 27 EU member states.
- ✅ Liability Mitigation: Serves as a robust defense in product liability claims.
Distinction: Harmonised (hEN) vs. European Standard (EN)
It is critical to distinguish between a standard that is merely “European” and one that is “Harmonised.” Only the latter carries legal weight under EU harmonization legislation.
| Characteristic | Harmonised Standard (hEN) | Standard European Norm (EN) |
|---|---|---|
| Initiator | European Commission (Mandate) | Industry / National Bodies |
| Legal Status | Presumption of Conformity | Voluntary Best Practice |
| OJEU Citation | Yes (Required) | No |
| Annex Z / ZA / ZB | Yes (Maps clauses to EU Law) | No |
Scope of Application
Harmonised standards form the technical backbone of the “New Legislative Framework.” They are the primary compliance tool for major industrial sectors, including:
Implementation Protocol
- Regulatory Identification: Determine the applicable EU Directives for your product.
- OJEU Consultation: Consult the Official Journal to identify valid Harmonised Standards for those Directives.
- Acquisition & Review: Purchase the official EN document. Verify the inclusion of Annex Z.
- Gap Assessment: Evaluate your product against the specific clauses listed in Annex Z.
- Technical Documentation: Reference the specific Harmonised Standards in your Technical File and Declaration of Conformity (DoC).
📥 Search & Download Harmonised Standards
Access the official European Standards library. Search by EN number or keyword to find the document required for your Technical File.
⚠️ Official PDF Standards starting from €60.60
Immediate Digital Delivery (PDF).
Frequently Asked Questions
What is the “Presumption of Conformity”?
It is a legal concept whereby a product is automatically presumed to comply with the essential requirements of an EU Directive if it fully complies with the relevant Harmonised Standards cited in the Official Journal. This shifts the burden of proof from the manufacturer to the surveillance authorities.
Why is Annex Z critical?
Annex Z (or Annex ZA/ZB/ZC) is the informative annex found only in harmonised versions of standards. It provides a correlation table linking the technical clauses of the standard to the specific legal requirements of the EU Directive. Without this annex, the link to the Directive is not explicitly defined.
Can I use an ISO or IEC standard instead?
To benefit from the presumption of conformity, you must use the EN version (e.g., EN ISO 13485, not ISO 13485). While technical content may be identical, only the EN version is legally recognized under the EU harmonization framework.
Where can I find the list of current Harmonised Standards?
The lists are published and updated by the European Commission in the Official Journal of the European Union (OJEU). Manufacturers must ensure they are using the currently cited version, as standards are periodically withdrawn and replaced.