Labelling Requirements – Swiss Authorized Representative
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:
|CH-REP Symbol / Indication to be placed on
|Class I MDR Device
|With effect from 26 May 2021 Until 31-Jul-2023 Where: Either on the label (or) On the Document accompanying the device After 31-Jul-2023 Where: 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
Representation / Usage of the “CH-REP” Symbol on the Device packaging
- The name of the Swiss AR must be available on the product label.
- The Name and Address of the Authorised Representative (AR) must appear adjacent to the symbol.
- The mentioned Address must enable provision to contact the Swiss AR with sufficient contact details.
- 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 harmonised 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:
“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.
Source Reference Links
MedDO Ordinance – Swiss MedDO 812.213
MedDO Article 51 – Obligations of Swiss AR
MedDO Article 104a – Timeline to Appoint AR
Swiss Medical Device Labelling Requirements – Chapter III of Annex I to EU-MDR 2017/745
What does “In a document accompanying the device” mean and where should I make this information available?
This information can be affixed to the device or be available separate from the device. Available separate refers to documents such as delivery notes, customs documents, guarantee certificates, invoices, a sticker on the packaging or the instructions for use.
Such documents are made available with the device throughout the supply chain route. It is available until it reaches the distributors and need not be necessarily available to the end customer. Note that this accompanying interpretation differs from the Swiss with EU MDR.
Is the definition of a “document accompanying the device” of Swiss MedDO and Europe’s MDR 2017/745 the same?
No, they are not the same. The interpretation of document accompanying the device definition differs from Swiss MedDO and EU MDR.
In what languages must the medical device product information such as Labelling and Instructions for Use be written for the Swiss market?
It must be written and made available in all three official languages of Switzerland (German, French and Italian). Symbols established by using technical standards may be used to replace the written statements.
What are the other obligations of a Swiss AR / CH-REP?
A detailed obligation/responsibilities of a CH-REP are available in our article Obligations of the Swiss Authorised Representative.
Who are the Economic Operators required to be registered with Swiss medic?
- Manufacturers (or) their Swiss Authorised Representative must register themselves within three months of placing the device for the first time in the Swiss market.
- During registration, they must cater information as per Part A of Annex VI EU MDR 2017/745. Further obligations and registration modalities are governed by Article 30 and Article 31 of EU MDR 2017/745