Our service
Swiss AR Services GmbH offers the Swiss Authorized Representative for Medical Devices and In Vitro Diagnostics as a service.
Core business
Daily Life
The Swiss AR Issue Tracker provides an easy way for communication and tracking of customer complaints, business related tasks or other relevant actions between the legal manufacturer and Swiss AR Services GmbH as the authorized representative.
The legal manufacturer is obliged to inform the AR in case of product changes, process changes and serious adverse events in third markets. The manufacturer may therefore have to adapt internal processes such as change control or even post market surveillance processes.
Regulation
MDR / IVDR
Switzerland has adapted its Medical Devices Ordinance (MepV) to the MDR of the European Union (Regulation (EU) No. 2017/745) and will enter into force on May 26, 2021. According to the new version of the MepV, non-Swiss manufacturers need a Swiss-based Swiss-Rep (Swiss-Rep / CH-Rep stands for "Swiss Authorised Representative") to continue selling their CE-marked medical devices in Switzerland. Since the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (incl. EU MDR) has not been updated, medical device manufacturers outside Switzerland must authorize a Swiss-Rep.
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.
Services
Our offer for you
Swiss AR Services GmbH offers the Swiss Authorised 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 carry out our onboarding with you quickly and easily and then act as the Swiss representative for your products.
We are happy to present our process to you here.
Services
Everyday
The Swiss AR Issue Tracker provides an easy way for communication and tracking of customer complaints, business related tasks or other relevant actions between the legal manufacturer and Swiss AR Services GmbH as the authorized representative.
The legal manufacturer is obliged to inform the AR in case of product changes, process changes and serious adverse events in third markets. The manufacturer may therefore have to adapt internal processes such as change control or even post market surveillance processes.
Services
A fast onboarding process
The onboarding process is streamlined and geared towards quick access to the market. All the necessary forms are already prepared.
The specific documents required under MDR Art. 11 (3)a must be submitted and will be checked for completeness and formal correctness by Swiss AR Services.
The general onboarding process includes six steps.
Letter of Intent
Contact details and product sales information
NDA
Non-disclosure agreement between manufacturer and authorised representative
Questionnaire
Detailed questionnaire on cooperation between manufacturer and authorised representative
Producer Agreement
This is the basic contract for services as an authorised representative.
Review of technical documentation
Authorized representative verifies the declaration of conformity and that the products have been assessed according to Annex I of the MDR or MDD (depending on applicability)
Product approval
Once the manufacturer has corrected all findings, the product is listed in Annex I of the manufacturer agreement At this point, the authorised representative services begin.
Have we aroused your interest?
We will be happy to create an individual offer for you. Simply contact us by mail or by using the contact form.