European Authorized Representative
Manufacturer from outside the EU or EEA, require a representative within the EU / EEA in order to sell medical devices within the EU. This requirement of the Medical Device Regulation (EU) 2017/745 (MDR) is applicable for all medical devices from class I to III. As of 26th of May, 2021, the date of application of the MDR, this affects all medical devices by manufacturers that are outside the EEA and want to place their devices within the EU market. Without a fully updated Mutual Recognition Agreement (MRA) Swiss manufacturers are also required to have a european representative in order to sell their medical devices into the EU.
To adequately meet this need for EC-Representatives, Axxos GmbH has founded Axxos Germany, a company specifically offering the services as EC-Representative. Axxos GmbH is registered in Eudamed and DIMDI.
The institutional agreement between Switzerland and the EU is not signed yet and will hardly be signed until May 26, 2021. This means that as of 21 May 2021 a Swiss Representative will be required by swiss law due to the missing update to the MRA and the applicable swiss MedDo.
The Swiss Representative is required for all CE marked medical devices from manufacturers outside of Switzerland to be sold in Switzerland after May 26, 2021.
The requirements in article 11 of the medical device regulation 2017/745 (MDR) are also valid for the Swiss Representative.
The Swiss Axxos GmbH can act as Swiss Representative for EU manufacturers. Please contact Markus Wipf m.wipfnoSpam@axxos.noSpamch.