Labeling Requirements for the EU, UK and Switzerland In-Country Representative
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Table: Labeling Requirements
| Market | Required on Labeling? | What must be included? | Where must it appear? |
|---|---|---|---|
| European Authorized Representative (EU AR / EC-REP) | Yes | Name and address To minimize translations, use the EC-REP symbol | MDD/IVDD: Product label, outer packaging or Instructions for Use AIMDD: On the sales packaging MDR/IVDR: On the device label |
| UK Responsible Person (UKRP) | No: If only EU CE Marked Yes: If UKCA Marked | Name and address, with UK Responsible Person written in English above it A UKRP symbol has not been issued by the MHRA | EU CE Marking: N/A UKCA Marking: On product labelling or the outer packaging, or the Instructions for Use |
| Swiss Authorized Representative (Swiss AR / CH-REP) | Yes | To minimize translations, use the CH-REP symbol | MDR Class I: Before 31 July 2023 – On the label or in a document accompanying the device.
After 31 July 2023 – on the label. MDR Class IIa, IIb, III: On the label. MDD: If already on the market before 26 May 2021 – On the label, Instructions for Use or in a document accompanying the device. If newly placed onto the market after 26 May 2021 – On the label or Instructions for Use. AIMDD: If already on the market before 26 May 2021 – On the sales packaging and Instructions for Use, or in a document accompanying the device. If newly placed onto the market after 26 May 2021 – On the sales packaging and in the instructions for use. IVDR self-test: On the label. IVDR non-self-test: Before 31 March 2025 – On the label or in a document accompanying the device. After 31 March 2025 – on the label. IVDD: If already on the market before 26 May 2022 – On the label, outer packaging, Instructions for Use or in a document accompanying the device. If newly placed onto the market after 26 May 2022 – on the label, outer packaging or Instructions for Use. |
EU Labeling Language Requirements
Find out the translation requirements for each country.
Additional Information:
Europe
Additional Notes:
MDR/IVDR – If the device label is too small to include the EU AR information, it can instead appear on the packaging for each unit, and/or on the packaging of multiple devices.
United Kingdom
Additional Notes:
UKCA Marking is currently voluntary. In the meantime, the MHRA has granted a transition period, which allows manufacturers to place EU CE marked devices onto the Great Britain market.
Once a manufacturer obtains UKCA marking, the UKRP must be identified on the labeling. In cases with dual marking, i.e., if a manufacturer has both EU CE and UKCA marking, it is required to list the UKRP to be compliant with UK regulations. If the device is only CE marked, then the UKRP does not yet need to be added to the labeling.
For more information on the UKCA marking transition dates, please read: New Dates for UK Regulation & CE Marking
Symbol:
A UKRP symbol has not yet been released by the MHRA. However, a UKCA marking symbol (similar to the CE marking symbol) must be affixed when manufacturers obtain UKCA marking.
Switzerland
Additional Notes:
The required size of the symbol and accompanying information is not defined by Swissmedic, but both must be clearly legible to the naked eye.
