The abrogation date of the revised Medical Device Ordinance RS 812.213 (MedDO) in force on May 26th, 2021 aligns with the EU MDR (Reg. (EU) No. 2017/745). However, as of today, both legislations haven’t been recognized under Mutual Recognition Agreement (MRA). This implies that without such agreement both markets consider each other as third countries and require an Authorised Representative to sell their CE marked devices. If you don’t have a legal representation in the market contact us.
As per the definition in the revised MedDO, an Authorised Representative is determined as follows: “any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance”. Upon mutual acceptance of written mandate, AR becomes the representative of the foreign manufacturer before the Swiss competent authority (Swissmedic), and is jointly liable with the manufacturer for defective products.
Our offices are based in Biel, Switzerland since 2008 and in Žilina, Slovakia since 2015. Our footprint is strong and stable for many years. We will not let you down.
This is a case by case decision to accept a mandate. Our experienced team will review your Technical File and ensure your products comply with market regulations. All our employees adhere to strict confidentiality policies and all signed non-disclosure agreement. all under strict confidentiality. It is time to contact us for the next steps.
We are manufacturer and struggle with the same issues, we speak the same language and we understand you. We are fully equipped to provide an industrial service. Let’s talk.
We train and keep up-to-date, our employees and our clients, on the latest modifications and amendments. We secure and communicate on post market surveillance and ensure the products are safe for end users.
We act and provide services as Swiss/EU Authorised Representative (AR) for all medical devices. We establish strong regulatory support and documents conformity for Swiss market and EU market. We follow full compliance protocol as per the market regulations and the revised Medical Device Ordinance (MedDO) or revised EU MDR (Reg. (EU) No. 2017/745).
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The purpose of this system is to improve transparency and coordination of information regarding medical devices available on the EU market. Swiss market will also be required to register in this system.
don’t wait any longer
CONTACT OUR TEAM TODAY!
Contact an experienced regulatory professional to start the registration