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prSSH EN ISO 15223-1:2021/A1:2025

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/Amd 1:2025)

General information

10.00     Feb 10, 2026

DPS

DPS/KT 6

European Norm

01.080.20     11.040.01  

Related directives

Directives related to this standards.

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Directive 2017/746
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Directive 2017/745

Life cycle

NOW

IN_DEVELOPMENT
prSSH EN ISO 15223-1:2021/A1:2025
10.00 Proposal for new project registered
Feb 10, 2026

Related project

Adopted from EN ISO 15223-1:2021/A1:2025

Adopted from EN ISO 15223-1:2021/A1:2025 IDENTICAL

Adopted from ISO 15223-1:2021/Amd 1:2025 IDENTICAL