New EU harmonized standard update for IVD labelling symbols

The European Commission has published Implementing Decision (EU) 2026/1313, updating harmonized standards supporting compliance with the Regulation (EU) 2017/746 (IVDR).

This Decision amends Implementing Decision (EU) 2021/1195 by introducing an updated version of a key standard for symbols used in manufacturer information.

What’s new ?

• EN ISO 15223-1:2021/A1:2025 on symbols for labelling and information supplied by the manufacturer
• Introduction of a defined term for “authorized representative”
• Update of the EC REP symbol to remove country/region specificity

Why it matters

This standard is central to device labelling. Its update reinforces alignment with IVDR requirements and ensures consistency in manufacturer information across the EU.

The Decision entered into force upon publication, with a transition period until 17 June 2031 to allow manufacturers to adapt labelling and processes.

DOWNLOAD THE DECISION EU 2026/1313