Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.”
The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III).
For imported devices, the CH-REP should be indicated according to the below table:
Device Class
CH-REP Symbol / Indication to be placed on
Class I MDR Device
With effect from 26 May 2021 Until 31-Jul-2023Where: Either on the label (or) On the Document accompanying the device After 31-Jul-2023Where: On the label
Class IIa, IIb, III MDR Devices
With effect from 26 May 2021 Where: On the label
MDD/AIMDD Devices with EU/EEA manufacturer or EC-REP
With effect from 26 May 2021 Where:MDD – On label (or) Instructions for Use (or) In Document accompanying the device AIMDD – On sales packaging (and) Instructions for Use (or) In Document accompanying the device
MDD/AIMDD Devices without EU/EEA manufacturer or EC-REP
With effect from 26 May 2021 Where:MDD – On label (or) Instructions for Use AIMDD – On sales packaging (and) Instructions for Use
“CH-REP” Symbol
Representation / Usage of the “CH-REP” Symbol on the Device Packaging
1. The name of the Swiss AR must be available on the product label.
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2. The Name and Address of the Authorized Representative (AR) must appear adjacent to the symbol.
3. The mentioned Address must enable provision to contact the Swiss AR with sufficient contact details.
4. The symbol’s size and name are not defined; however, they must be adequately visible to the naked eye.
Symbols to Use
Where symbols are used, they must confirm to the harmonized standards. Swiss medic rule allows the sole use of the symbol without any description of the symbol explained in the product documentation enclosed.
Other CH-REP Representation(s)
Instead of the symbol, Swiss medic also permits the indication as stated below:
“CH-Authorised Representative”
“CH-REP”
“Authorised Representative for Switzerland”
Rules for Manufacturers from EU/EEA
Manufacturers placed in the EU/EEA also fall under this obligation to appoint their Swiss AR (called CH-REP or Swiss Rep or SAR). It is least expected that a single CH-REP is appointed for devices that belong to the same medical device group or family.
