Swiss Authorized Representative (CH‑REP)
Overview
Why appoint a CH‑REP? Switzerland is not an EU member and, after the EU’s MDR came into force, the prior Mutual Recognition Agreement with the EU was not renewed. Although Swiss law (MedDO and IvDO) was updated to align with MDR/IVDR, Switzerland is treated as a “third country.” Therefore, manufacturers without a registered Swiss establishment must appoint a local Swiss Authorized Representative.
Frequently Asked Questions
As your Swiss Authorized Representative we will:
Why appoint a CH‑REP? Switzerland is not an EU member and, after the EU’s MDR came into force, the prior Mutual Recognition Agreement with the EU was not renewed. Although Swiss law (MedDO and IvDO) was updated to align with MDR/IVDR, Switzerland is treated as a “third country.” Therefore, manufacturers without a registered Swiss establishment must appoint a local Swiss Authorized Representative.
What is the purpose of a Swiss Authorized Representative?
If you do not maintain a business presence in Switzerland, it is mandatory to designate a CH-REP to market medical devices, as stipulated by Swiss regulations.
Are there specific qualifications required for the Swiss Authorized Representative, such as industry experience or educational background?
No, Article 51 Paragraph 1 of the MedDo, as amended, simply references Article 11 of the MDR. However, it is essential for the Authorized Representative to possess sufficient in-house expertise and skills to fulfill the responsibilities outlined in that article. Without such qualifications, the liability mentioned in paragraph 5 of the MDR would be untenable.
Is there a counterpart to the Person Responsible for Regulatory Compliance (PRRC) in Switzerland, similar to that in the EU?
Yes, there is. Article 49 Paragraph 2 of the MedDo specifically refers to Article 15 of the MDR, including the associated qualifications. Interestingly, the PRRC of the CH-REP may be located in the EU if the CH-REP chooses to do so.
Is it necessary for the Swiss Authorized Representative to have their own Person Responsible for Regulatory Compliance (PRRC)?
Yes, the Swiss CH-REP must have its own PRRC, separate from the manufacturer.
Do we require a Swiss Registration number?
To reduce the risk of information loss and maintain effective market surveillance in Switzerland, it is essential for manufacturers, authorized representatives, and importers based in Switzerland to register with Swissmedic. Upon successful evaluation of the provided information, Swissmedic will issue a Swiss Single Registration Number (CHRN) to the applicant.
Where should the Swiss Authorized Representative be identified on our devices?
The CH-REP must be displayed on a labeling component accessible to the end-user at the point of use, such as on the shelf box or sterile packaging, ideally on the device label but not necessarily. The CH-REP’s information can also be included in the Instructions for Use (IFU) if it accompanies the product to the point of use, similar to the practice for the European Authorized Representative.
UK Responsible Person (UK REP)
Person Responsible For Regulatory Compliance (PRRC)
