Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and …
Continue reading “Why is Switzerland considered a Third Country by Europe?”
As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as …
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. …
Since Switzerland is considered a Third Country by the EU, its registration database is denied. Swiss REP and Importer in …
All Manufacturers located outside Switzerland who intend to start or keep marketing their own Medical Devices in Switzerland must designate …
Continue reading “Who is responsible for the CH REP Swiss Authorised Representative designation?”
According to Medical Devices Ordinance (MedDO) Article 104a, several transitional periods for the nominee of the Swiss Authorised Representative CH …
Since Switzerland is a Third Country, there is no CE certificate which is valid in Switzerland, that is to say …
Continue reading “Is CE certificate on Medical Devices valid in Switzerland?”
Deadlines for UDI (Unique Device Identifier) affixing change depending on Medical Devices risk classes. With regards to UDI affixing, Medical …
Continue reading “Which are the deadlines for UDI affixing?”
The Regulatory Authority Swissmedic provides accurate information on the usage of the Swiss Representative CH REP symbol which is very …
Continue reading “How must the CHE REP symbol be used on the device packaging?”
While CE certificate is no longer valid, the CE marking placed on the product is still valid. CE marking though …
Continue reading “Is CE marking still valid with Swiss – Exit?”