EC REP is becoming EU REP: Qhat medical device manufacturers need to prepare for
The symbol used to identify an Authorised Representative on medical device and IVD labelling is changing. Under the amended harmonised standard EN ISO 15223-1:2021/A1:2025, the familiar EC REP symbol is being replaced by EU REP.
The change reflects updated terminology. The European Union succeeded the European Community, making EU REP a more accurate description of the Authorised Representative established within the Union. The update does not change the legal role, responsibilities or location of the Authorised Representative, and it does not affect the safety, performance or intended purpose of a device.
Although the change is editorial, manufacturers still need to manage it carefully across their labelling, documentation and quality processes.
What exactly is changing?
EN ISO 15223-1:2021 currently includes the EC REP symbol for an Authorised Representative in the European Community or European Union. Amendment A1:2025 introduces the more generic XX REP concept, which can be adapted to a specific country or jurisdiction.
For an Authorised Representative established within the European Union, “XX” must be replaced by “EU”. The correct symbol will therefore become EU REP.
This change is particularly relevant to manufacturers located outside the European Union. Under the MDR and IVDR, these manufacturers must appoint a sole Authorised Representative before placing devices on the Union market.
A five year transition period
The amended standard was published as a harmonised standard on 17 June 2026. A five year coexistence period applies until 17 June 2031.
During this period, manufacturers may:
- continue using EC REP;
- introduce EU REP;
- use EC REP and EU REP on different packaging levels;
- implement the change gradually;
- use relabelling or overlabelling, provided the Authorised Representative information remains clear and understandable.
This gives manufacturers time to include the update within their normal packaging and labelling lifecycle, rather than launching a separate redesign project. Existing stock does not need to be discarded solely because it carries the EC REP symbol.
From 17 June 2031, manufacturers relying on the harmonised standard for presumption of conformity should use EU REP. Devices carrying EC REP that were already placed on the EU market before that date may continue to be made available.
No change to the Authorised Representative’s legal role
The terminology update does not change the mandate between the manufacturer and its Authorised Representative. The obligations under the MDR and IVDR remain unchanged.
The Authorised Representative must still perform the tasks assigned through the written mandate and act as the manufacturer’s regulatory contact within the European Union.
The MDCG guidance also confirms that manufacturers do not need prior approval from their Notified Body for this specific labelling change, where Notified Body involvement otherwise applies. The update can therefore generally be managed through the manufacturer’s internal change control process.
What manufacturers should review
Even though this is not a safety or performance change, it affects several controlled documents and operational processes. Manufacturers should identify everywhere the EC REP symbol is currently used and prepare a structured transition.
Relevant areas may include:
- product labels and packaging artwork;
- instructions for use;
- symbol libraries and legends;
- technical documentation;
- references to EN ISO 15223-1;
- change control records;
- artwork specifications;
- instructions provided to suppliers, distributors or packaging partners.
Manufacturers should also verify that the name and address of the Authorised Representative remain clear and consistent throughout all packaging levels and documentation.
A practical implementation approach
The long transition period allows manufacturers to avoid unnecessary waste and disruption. For most organisations, the most efficient approach will be to introduce EU REP during the next scheduled update of the label or packaging.
A practical action plan includes:
- Identifying all products and SKUs that currently use EC REP.
- Confirming which products require an Authorised Representative.
- Updating central artwork and symbol libraries to EU REP.
- Recording the update through the existing change control process.
- Updating standard references to EN ISO 15223-1:2021/A1:2025.
- Coordinating the rollout with relevant suppliers and distribution partners.
- Completing the transition for newly placed devices before 17 June 2031.
This is a terminology transition, not a redesign or recertification exercise. However, delaying action until the end of the coexistence period could create unnecessary pressure across product portfolios, suppliers and packaging processes.
How AR Experts can support you
AR Experts can help manufacturers assess the impact of the transition across their product portfolio and Authorised Representative documentation.
Our specialists can support you with:
- reviewing labels and packaging for Authorised Representative information;
- identifying products and artwork affected by the symbol change;
- checking consistency between labelling, technical documentation and the AR mandate;
- supporting the transition from EC REP to EU REP within your change control process;
- reviewing your broader MDR or IVDR authorised representative obligations.
By planning the update as part of your normal labelling lifecycle, you can remain compliant while avoiding unnecessary waste, standalone redesign projects and operational disruption.
Need support preparing your transition to EU REP? Contact our regulatory specialists.
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