Last updated: 14 November 2023
See all updates at the end of this post.
Swissmedic has published guidance on the requirement for Swiss authorised representative (CH-REP) for medical devices.
Definition of a Swiss authorised representative
Natural or legal person in Switzerland who has been mandated in writing by a manufacturer established in a foreign country to act on the manufacturer’s behalf in relation to specified tasks in accordance with MedDO; Art. 4 para. 1 let. g MedDO.
When does a manufacturer require a Swiss authorised representative?
A manufacturer of a medical device requires a Swiss authorised representative if it does not have its registered place of business in Switzerland. Its products may be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 paragraph. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU.
Are there any transitional periods for the above requirement?
Yes there are. The transitional periods defined in Art. 104a MedDO apply to the Swiss authorised representative.
Manufacturers based in an EU or EEA state or having an authorised a person based in an EU or EEA state, must appoint a Swiss authorised representative for all products that are placed on the market after May 26, 2021 as follows:
| Device Class | Date by which a Swiss Authorised representative must be appointed |
|---|---|
| -Class III -Class IIb implantable devices -Active implantable devices | by December 31, 2021 |
| -Class IIb non-implantable devices -Class IIa devices | by March 31, 2022 |
| Class I products | by July 31, 2022 |
For systems and treatment centers, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by July 31, 2022.
Is it a requirement to state the Swiss authorised representative on a medical device and the packaging of a medical device?
The name of the Swiss authorised representative must be stated on the packaging (“product labelling”) as per Medical Devices Regulation (MDR) Annex I section 23.2 (d).
It is not mandatory for the Swiss authorised representative to be stated:
- on the product itself
- in the instructions for use (IFU) as per MDR Annex I section 23.4 (a)
- or in the documents enclosed with the product (delivery note, commercial invoice).
Where on the medical device packaging must the details of the Swiss authorised representative be placed?
The name and address of the authorised representative must appear adjacent to the “CH-REP symbol”. The address must enable contact to be established with the Swiss authorised representative. It is not sufficient only to state the P.O. box number, an e-mail address or a telephone number.
Notification for mandate as Swiss authorised representative (CH-REP)
Link here to the form for notification for mandate as Swiss authorised representative.
Further information
You can find further information on the Swiss authorised representative (CH-REP) in the information sheet entitled Information sheet Obligations Economic Operators CH available on this page. The information sheet was last updated on 1 November 2023 due to a new version of the MedDO / IvDO.
Practical interpretation on the requirements of an authorised representative (CH-REP) for drug-device combination products is provided in this blog post.
Between March and May 2022, Swissmedic inspected a randomly generated sample of 20 Swiss authorised representatives registered with Swissmedic throughout Switzerland. Information, including about their operating models, was recorded to obtain a general overview of the market situation. You can read more about the inspection here.
Source: Swissmedic
Updates
| Date | Update |
|---|---|
| 14 Nov 2023 | The first paragraph under the section Further information was updated to add the following sentence: “The information sheet was last updated on 1 November 2023 due to a new version of the MedDO / IvDO.” |
| 4 October 2022 | Section entitled Further Information updated to add more links to useful information. |
| 10 January 2021 | 1) Section entitled Further Information added. 2) The following sentence was added to the section entitled When does a manufacturer require a Swiss authorised representative? This also applies to manufacturers with their registered place of business in the EU. |
| 30 December 2021 | Section entitled Definition of a Swiss authorised representative added. |
| 24 December 2021 | Section entitled Notification for mandate as Swiss authorised representative (CH-REP) added. |