The Implementing Regulation (EU) 2021/2078 of November 26th, 2021, published on the Official Journal of the European Union, lays down …
Continue reading “EUROPE: published the Implementing Regulation (EU) 2021/2078 on EUDAMED”
If you are a Manufacturer of Medical Devices with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or …
If you are a Manufacturer of Medical Devices with a valid certificate issued by a Notified Body under Directive 90/385/EEC …
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?”