Metecon Schweiz GmbH: Your partner for regulatory compliance in Switzerland

In the summer of 2023, we embarked on a new venture. We launched Metecon Switzerland as a new regulatory compliance partner for our Swiss clients and manufacturers seeking to distribute Medical Devices or In vitro diagnostics (IVD) in Switzerland. Metecon Switzerland provides comprehensive support to clients both within and outside of Switzerland with national and international regulatory affairs.

Why did we take this step? The Mutual Recognition Agreement (MRA) between the EU and Switzerland was not renewed and since then the Swiss ordinances for medical devices (SR 812.213; MedDO) and for IVDs (SR 812.219; IvDO) have become authoritative for market access in Switzerland.

To offer our clients optimal support under this new framework, Metecon Switzerland is now taking over regulatory services in Switzerland. Whether it is a matter of reviewing, revising or creating technical-documentation documents, optimizing or establishing a quality management system or providing other consulting services for approval in Switzerland or abroad - Metecon Switzerland boasts a team of experts ready to meet your needs.

Furthermore, Metecon Switzerland is a valuable partner for clients outside Switzerland aiming to launch their products in Switzerland. For this purpose, a Swiss Authorised Representative (CH-REP) is required, as stipulated by the MepV (Art. 51) and the IvDV (Art. 44) - Metecon Schweiz GmbH also provides this service.

The contact person for all services of Metecon Switzerland is Marco Scicolone. He has joined the Metecon team at October 1, 2023, following positions at Stryker Osteonics, Dräger Schweiz (Switzerland) and as a founder and entrepreneur in the hospital supply sector, among others. We at Metecon are glad that we could win him for Metecon Switzerland!

The next opportunity to meet Marco Scicolone from Metecon Switzerland as well as Oliver Schaer (Business Development at Metecon GmbH) is the Swiss Medtech National Regulatory Conference in Bern on 18 October 2023. Both look forward to exchanging ideas with you on site. For further information and ticket details, please visit at National Regulatory Conference 2023 | Swiss Medtech.

Marco Scicolone is looking forward to hearing from you. The Metecon Switzerland experts are fully prepared to assist you with your concerns in the Swiss market!

Marco Scicolone        Our office address in Switzerland
Business Development
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Metecon Schweiz GmbH
Weltpoststrasse 5                3015 Bern
        +41 79 8682020

Our blog posts are researched and created with the utmost care, but are only snapshots of the regulations, which are constantly changing. We do not guarantee that older content is still current or meaningful. If you are not sure whether the article you have read on this page still corresponds to the current state of regulation, please contact us: we will quickly place your topic in the current context.

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Regulatory History: Blog Archive

You can find older posts in our blog archive. Please make sure that this content is up to date before using it; we are happy to help.