Swiss AR Services
Swiss Authorized Representative for Medical Devices
and In vitro Diagnostics
Six steps to CH-REP
Thanks to our lean processes , we
register your products after just six steps!
the jungle of laws
The challenge
Find out more about the subject by watching our short video.
Professional
Your solution
Swiss AR Services AG offers the Swiss Representative for Medical Devices and In Vitro Diagnostics as a service. Through our contracts and processes, which are specially adapted to the CH-REP requirements, we can quickly and easily carry out our onboarding with you and then act as the Swiss representative of your products.
Get in touch with us today
Swiss authorized representative
Core business
Daily Life
The Swiss AR Issue Tracker provides an easy way to communicate and track customer complaints, business-related tasks or other relevant actions between the legal manufacturer and Swiss AR Services AG as the authorized representative.
MDR / IVDR
Regulation
personal & business
Privacy
Using our specially configured Swiss AR Issue Tracker, we manage the documents on our own servers and additionally benefit from an easy way to communicate, track customer complaints, business-related tasks or other relevant actions between the legal manufacturer and Swiss AR Services AG as the authorized representative.
Professional
Lean processes
In order to be able to react faster, more flexibly and more efficiently to market and customer requirements, our processes are always optimized according to Lean Administration. The general onboarding process comprises a crisp six steps.
Our service
The key to the Swiss market!
Through a high level of customer satisfaction, the necessary know-how and our lean processes, we accompany you as Swiss representatives without detours to your goal.
Do you have any questions?
FAQ
We are here for you 5 days a week and answer within the shortest possible time. Enclosed you will find already in our FAQ the answers to the most frequently asked questions.
Contact us today via our contact form.
Due to the failed negotiations on a new framework agreement between the EU and Switzerland, conformity assessment of medical devices will no longer be mutually recognised since the MDR comes into force (26.05.2021).
In order to continue to market medical devices in Switzerland, all MDD/MDR devices, as well as Class I, II & III treatment units, must be registered by 31 July 2022.
The following deadlines apply to in vitro diagnostic products:
(IVDD/IVDR)
- Until 31 Mar 2023 - Class D
- Until 31 Mar 2023 - Classes C and B
- Until 31 Jul 2023 - Class A
No.
We only check that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out an appropriate conformity procedure, if applicable.
We will be happy to recommend an appropriate contact for this purpose. Please contact us for this purpose using the contact form.
We offer the service as CH-REP for medical devices as well as for IVD products.