Welcome by CH - REP.COM
Since 26 May 2021, Switzerland has been considered as a third country status to the EU.
Mutual recognition of conformity assessment procedures no longer applies. This means that foreign manufacturers of medical devices in Switzerland must appoint an "Swiss Authorised Representative" (SAR).
Importer have to register in terms of foreign trade law. An importer is the person who concludes sales contracts for goods e.g. medical device, with foreign exporter or who imports the goods into the Swiss and placed on the market.
A SAR is a natural or legal person established in Switzerland who is mandated in writing by a manufacturer abroad to perform certain tasks on his behalf in fulfilment of the manufacturer's obligations arising from this Ordinance.
CH - REP.com is an conglomerate of several independent service companies in medical technology in the field of quality and regulatory with the aim of jointly addressing the challenges relating to the lack of MRA and the coming into force of the MDR and to find pragmatic solutions.