Harmonised Standard
Harmonised standards arise from standardisation mandates issued by the European Commission to the European standardisation bodies CEN, CENELEC, or ETSI. They are published via reference in the EU Official Journal (OJ) as a 'list of harmonised standards' for each regulation.
Presumption of conformity: where a product complies with a harmonised standard referenced in the OJ, it is presumed to meet the essential safety requirements of the associated EU regulation (e.g. EN 455 for MDR, EN 388 for PPE Regulation). This presumption is rebuttable.
Harmonised standards are not legally mandatory - manufacturers may demonstrate conformity by other means. However, applying them is the simplest and most common route to CE marking.
Distinct from harmonised standards:
- International standards (ISO, IEC): no CE presumption of conformity without OJ reference
- National standards (DIN, BS, NF): no EU-wide harmonisation effect
The harmonisation framework is governed by EU Regulation (EU) 1025/2012 on European standardisation.
Frequently asked questions
What does presumption of conformity mean for harmonised standards?
Where a product complies with a harmonised standard referenced in the EU Official Journal, it is presumed to meet the essential requirements of the associated EU regulation. This significantly simplifies the conformity assessment procedure.
Are harmonised standards legally mandatory?
No. Harmonised standards are voluntary. Manufacturers may use other technical specifications but must then demonstrate compliance with the essential requirements of the EU regulation by other means.
What is the difference between a harmonised standard and an ISO standard?
ISO standards are international standards without automatic EU presumption of conformity. Once an ISO standard is adopted as a harmonised standard at EU level and referenced in the Official Journal (e.g. EN ISO 374-1), the presumption of conformity applies.