Decomplix becomes your professional compliance partner. We guide you to your CE mark and ensure your compliant quality management. You get expert advice on how to overcome key regulatory hurdles on the way to getting your product to market.
More about our CE mark servicesAs your Swiss Authorised Representative (CH-REP), we ensure your market access in Switzerland. Our high level of compliance and regulatory knowledge was confirmed with a Swissmedic inspection with no non-conformities in April 2022.
More about our CH-REP serviceWe offer consulting, training and ready-to-use templates for procedures, checklists and other tools for the compliant import of medical devices into Switzerland. Our proven experts tailor the processes together with you to your needs for fixed price.
More about our importers service100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Read more about us«It feels very good to have Decomplix as CH-REP.»
«Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
«Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.»
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.»
«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»
«Decomplix provided valuable expertise for understanding the regulatory framework of medical device, data protection and IT security.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software and what rules apply in the development.»
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»
MedTech Europe/COCIR
Swissmedic
BW690_00_001defi_FO Orders for export certificates for medical devices
European Union
Reg. (EU) 2023/2482 amending REACH — Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:
MedTech Europe
Position paper – The Future of Europe’s Medical Technology Regulations
Ensuring efficiency, for example:
Embracing innovation, for example:
Effective governance, for example:
MedTech Europe/COCIR
Swissmedic
BW690_00_001defi_FO Orders for export certificates for medical devices
European Union
Reg. (EU) 2023/2482 amending REACH — Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:
You will receive regular updates around regulation of medical devices.
