Medical Devices CH Rep
Authorized Representative in Switzerland
Representation and Import Services for Medical Device Manufacturers
Our experience and regulatory expertise ensure 100% compliance of distributed products with legislation. All products we handle can be marketed in Switzerland, with Élite Med Group often serving as the Authorized Swiss Representative (CH REP).
We act as Authorized Representative and importer under Swiss MedDO and ODiV regulations.
Medical devices in Europe and in countries adhering to CE marking are governed by Regulation (EU) 2017/745, which, with some exceptions during the transition period, repealed Directives 93/42 and 90/385. The same applies to Regulation (EU) 2017/746, which repealed Directive 98/79.
Élite Med Group can also be a valuable partner for facilities such as clinics and hospitals, conducting management system audits and ensuring compliance of devices used.
What is a Swiss Authorized Representative for Medical Devices?
Authorized Representative
A Swiss Authorized Representative is any natural or legal person established in Switzerland, responsible for acting on behalf of the manufacturer to assist in regulatory matters within the Swiss market. Switzerland has never been a member of the European Union, but in the interest of ensuring a smooth bilateral flow of goods across borders, it has traditionally signed Mutual Recognition Agreements (MRAs) with the EU. When the EU Medical Device Regulation (MDR) came into force, an agreement to renew the MRA on medical devices had not been reached. Despite Swiss updates to their Medical Devices Ordinance (MepV, MedDO) to closely mirror the MDR, Switzerland became a ‘third country’ to the EU, similar to the UK.
Therefore, manufacturers of medical devices and IVDs without a legal presence in Switzerland must now appoint a local Authorized Swiss Representative (CH REP) and a Swiss importer to continue selling in Switzerland.
Élite Med Group’s Role as CH REP
Élite Med Group stands out as a reliable CH REP for numerous medical device manufacturers With our deep understanding of Swiss and international regulations, we ensure all products comply with current laws. We act as Authorized Representative and importer under Swiss MedDO and ODiV regulations, ensuring devices can be marketed smoothly in the Swiss market.
As an authorized Swiss representative, Élite Med Group provides comprehensive regulatory support, including verification of medical device compliance according to Regulation (EU) 2017/745 and Regulation (EU) 2017/746. We also collaborate with clinics and hospitals to ensure their management systems align with current regulations.
Trust Élite Med Group for Regulatory Compliance
If you are a medical device manufacturer looking to operate in Switzerland, trust Élite Med Group as your reliable CH REP. We offer complete solutions to ensure your products meet all Swiss regulations and can be sold seamlessly in the market.
Are you a medical device manufacturer and looking for a CH REP? Contact us!
Find out how we can guide you through the Swiss regulatory landscape and ensure the success of your products.
