Swiss Representative Services
Since 31.07.2022, various MDD/ MDR products of class I, II & III, as well as treatment units, must be registered.
Switzerland has adapted its medical device regulation (MepV) to the medical device regulation (MDR) of the EU.
As a consequence, non-Swiss manufacturers of medical devices need a Swiss authorized representative to start or continue selling their products on the Swiss market.
We are an experienced service provider in the field of medical devices and specialized in supporting manufacturers from abroad who wish to launch their products on the Swiss market or continue to selling them. With our Swiss Representative offer, we take responsibility for your product in terms of compliance with regulatory requirements and communication with the relevant authorities.
This includes the verification of the EU Declaration of Conformity, as well as the registration obligations and necessary documentation. As a result, you are always up to date with product registration and can focus entirely on your core competencies, while we take care of all the necessary steps to successfully place your product on the Swiss market.
As Swiss Representative, we take responsibility for your product in terms of compliance with regulatory requirements, if necessary including audits and compliance with medical device regulations. This also includes support with approval and registration, as well as the preparation of documentation such as technical files and risk assessments.
In a first step, you get in contact with us and a NDA is signed for the start of a trustfull partnership.
In the second step, we collect general data on your products and make a competitive offer on the CH-REP service.
After a review of the relevant parts of the Technical Documentation, the declaration of conformity and a check that the products have been assessed in accordance with Annex I of the MDR or MDD, we give advice on possible improvements, before a Mandate Agreement is signed and PrimaMed carries out the registration processes.
