Manufacturers need to consider the different labeling requirements for listing their in-country representatives in the EU, UK and Switzerland.
The table below contains a high-level overview of the key requirements. Additional notes for the EU, United Kingdom and Switzerland are included below the table.
Market |
Required to be on labeling? |
What must be included? |
Where must it appear? |
|---|---|---|---|
| European Authorized Representative (EU AR / EC-REP) | Yes | Name and address. Strongly recommended to use the EC-REP symbol, to help minimize translations. |
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 leveraging EU CE Marking Yes – If leveraging UKCA Marking |
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 UK CA Marking: On product labelling or the outer packaging, or the Instructions for Use |
| Swiss Authorized Representative (Swiss AR / CH-REP) | Yes | Name and address. Strongly recommend to use the CH-REP symbol, to help minimize translations. |
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 document accompanying. 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. |
Try our Language Requirements Tool. Find out the labeling requirements for Europe, Switzerland and the UK.
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.
Symbol:
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: MHRA Postpones UKCA Marking Deadline
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.
Additional Notes:
The required size of the symbol and name are not defined by Swissmedic
, but both must be clearly legible to the naked eye.
Transition dates are granted to appoint the Swiss AR, if the device is already on the market. Any devices newly CE marked require immediate appointment of the Swiss AR.
For more information on AR appointment deadlines, please read: Swiss Authorized Reresentative
Symbol:
The CH-REP symbol files are located on Swissmedic’s website: HERE
In place of the symbol, it is permissible to instead write “CH authorised representative” / “CH-REP” / “Authorised representative for Switzerland”. However, should manufacturers opt to do this, they must consider translation requirements.
Regulatory Citations
EU: MDD 93/42/EEC– Annex I, Article 13.3(a), IVDD 98/79/EC – Annex I, Article 8.4(a), AIMDD 90/385/EEC – Annex I, Article 14.2, MDR 2017/745 – Annex I, Chapter 3, Article 23.2(d), IVDR 2017/746 – Annex I, Chapter 3, Article 20.2(d)
United Kingdom: Regulating medical devices in the UK – GOV.UK
Switzerland: MDR – MedDO Art. 16 para. 1 in conjunction with Annex I point 23.2 (d), MDD/AIMDD – MedDO Art. 7 para. 1 let. a and b in conjunction with Annex I point 13.3 and Annex I points 14.2 indent 1 and 15 indent 2, Economic Operators PDF
