Welcome to Metecon Switzerland LLC, your experienced partner for regulatory compliance of medical devices and in vitro diagnostics (IVDs)! We represent Swiss manufacturers as European Authorized Representative (EC-REP) within the EU and ensure that their product obtains and permanently retains the CE marking. We represent manufacturers who are not based in Switzerland and are looking for Swiss market access as Swiss Authorized Representative (CH-REP).With us, everything revolves around the documentation, market access and post-market surveillance of your products. Since 1999, Metecon GmbH, based in Mannheim (Germany), has been providing standards- and regulatory compliance consulting and support for the market access and post-market surveillance of medical devices and IVDs. With the founding of Metecon Switzerland LLC in 2023, we also simplify your path to regulatory compliance and help you to bring your products to market in your target markets - efficiently and safely.
How can we support you?
360° Regulatory Compliance
Our experienced team of over 60 regulatory compliance experts will always find a reliable and safe solution for your individual requirements. So that your medical devices/ in vitro diagnostics (IVDs) comply with the regulatory requirements at every point in the product life cycle: Documentation, quality management according to ISO 13485 or other QM requirements, verification and validation, access to market and post-market surveillance - together we will provide you with the decisive competitive advantage!
European Authorized Representative (EC-REP)
Are you a Swiss manufacturer of a medical device or in vitro diagnostics (IVDs)? As your European (EU) Authorized Representative (EC-REP), we offer you all the safety and services you need for fast and reliable market access in Europe.
Swiss Authorized Representative (CH-REP)
Are you an international manufacturer or EU manufacturer? do you want to place your medical device/IVD on the Swiss market?
As your trusted CH-REP (Swiss Authorized Representative for Medical Devices or Swiss Authorized Representative for In Vitro Diagnostics) in Bern (CH), we are happy to provide you with active and well-versed support.
Mastering the challenges: MDR, IVDR, MedDO, IvDO & Co.
Swiss medical device and IVD manufacturers are currently facing a number of regulatory challenges, particularly related to their access to the European market and the implementation of the new EU Ordinances for medical devices and in vitro diagnostics (IVDs).One of the biggest challenges is "compliance" with the two EU regulations Medical Device Regulation (Regulation (EU) 2017/745 (MDR)) and In Vitro Diagnostics Regulation (Regulation (EU) 2017/745 (IVDR)). The MDR and IVDR set significantly higher requirements for clinical evaluation, technical documentation, and post-market surveillance of medical devices and in vitro diagnostics (IVDs), and also affect CE marking, classification and compliance with the new EU database EUDAMED and registration systems. Swiss companies operating in the EU will therefore need to ensure that they meet all requirements to market their products in the European market.Another issue is the equivalence of Swiss ordinances compared to EU regulations. With the failure of the framework agreement (MRA: Mutual Recognition Agreement), Swiss companies are facing additional regulatory challenges to place their products in the EU market. Medical devices placed on the market or brought into operation in Switzerland must meet the requirements of the Medical Devices Ordinance (MedDO, SR 812.213) or the requirements of the Ordinance on In Vitro Diagnostics (IvDO, SR 812.219).Overall, as a Swiss medical device or IVD manufacturer, you have to operate in a rapidly changing regulatory environment and face numerous challenges in order to successfully sell your products in the European and international markets. Working closely with external experts like us can help you to ensure regulatory compliance and minimize regulatory risks.Get to know us! Take advantage of our experience and simplify your path to regulatory compliance.
Registration of medical devices and in vitro diagnostics in Switzerland
Since April 2022, Swissmedic has been working on the implementation of a database comparable to EUDAMED: the Swissdamed - Swiss Database on Medical Devices. Registrations will only become mandatory once the relevant amendments to MedDO/IvDO have been made. The implementation of the regulatory requirements in MedDO and IvDO as well as the launch of the Swissdamed database are planned for 2023.We will keep you informed as soon as there is news on this.
