PhaRegistrum · Originally published on 17/09/2026
There is an update to the information supplied by medical device manufacturers. Commission Implementing Decision (EU) 2026/1313 introduces a change to the harmonised standard on symbols used in the information supplied by the manufacturer.
What changes? The EU REP symbol replaces the current EC REP symbol, reflecting the terminology currently used by the European Union.
A transition period applies. Until 17 June 2031, both EC REP and EU REP may be used, provided the information about the authorised representative remains clear.
Devices bearing the EC REP symbol that were placed on the EU market before that date may continue to be made available.
Do you have questions about adapting your medical device documentation or labelling? Contact PhaRegistrum.
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