Glossary
Harmonised standard
A harmonised standard is a technical standard, developed by a European standards body and published in the EU Official Journal, that gives a presumption of conformity with the essential requirements of a directive or regulation when applied in full. Great Britain has its own equivalent list of designated standards.
Why it matters
Testing against the right harmonised or designated standard is usually the fastest route to a defensible technical file. Using an outdated or wrong standard version is one of the most common gaps market surveillance authorities find, since cited standards and their versions change over time.