End-to-end swissdamed device registration — handled by your CH-REP.
As your CH-REP, Decomplix manages the full swissdamed device registration process — from data verification to “on-the-market” status, and any subsequent changes in product data. We offer a fixed fee with clearly defined deliverables, so you know the cost before you commit.
Product registration in swissdamed becomes mandatory for medical devices, IVD, Procedure Packs and Systems on 1 July 2026. If your devices are not registered, a vigilance event after that date triggers immediate registration with no transition period. The time to act is now.
For a full explanation of CH-REP obligations under the Swiss Medical Devices Ordinance (MedDO, SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219), read our guide on Swiss Authorised Representatives.
Beni Hirt has over 15 years of experience in customer relations and project management, particularly in software and business modeling. Beni Hirt builds and maintains partnerships with start-ups, SME, and big entities and supports them to clear regulatory hurdles and shorten the time to market. He is a business administrator and experienced in establishing and running new businesses and models. He also has co-founded and ran one of the most successful Swiss app agencies.
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Why Decomplix as your partner
ISO 13485-certified QMS — our quality management system, certified by an independent accredited body, meets the same standard we help our customers achieve.
Zero Swissmedic non-conformities — a successful Swissmedic inspection of our CH-REP operations confirmed our compliance level.
Mandate-anchored process — we verify your data against your specific CH-REP mandate scope and report discrepancies at cell level.
Fixed-fee transparency — you know the cost before you commit. No hourly billing, no scope creep, clearly defined deliverables.
End-to-end service — from data verification to “on-the-market” status and subsequent product data updates, your CH-REP handles the full process.
«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»
«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.»
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«It feels very good to have Decomplix as CH-REP.»
«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»
«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
«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.»
«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.»
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»
«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»
«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.»
It is the Swiss database for medical devices, IVD, Procedure Packs and Systems. Similar to EUDAMED, it contains information about Swiss economic operators (in the “Actors” module) and products placed on the Swiss market (in the “UDI” module). Contrary to EUDAMED, it does not include modules for Notified Bodies and certificates, clinical investigations and performance studies, Vigilance and PMS, or market surveillance.
All economic operators placing medical devices on the Swiss market must register as actors: Any Swiss-based company that undertakes activities as a device manufacturer, System or Procedure Pack producer, CH-REP, or importer must register as an “Actor”. For UDI device registration, the CH-REP of a foreign manufacturer owns the data integrity obligation and manages the registration process.
Registration of devices (medical devices and IVD), Systems and Procedure Packs in swissdamed’s UDI module. Custom-made devices are excluded. Devices subject to a Master UDI-DI (e.g. spectacles, contact lenses) are addressed at separate stages.
Yes, with one exception. If a Vigilance case must be reported to Swissmedic after 1 July 2026 for a device not yet registered in swissdamed, immediate registration is required — the transition period does not apply.
No. A CHRN (Swiss Registration Number) is assigned when an economic operator registers for the corresponding economic operator role in swissdamed’s Actors module. Device registration in swissdamed’s UDI module is a separate, additional obligation. Having a CHRN does not mean that devices are registered.
Only if the CH-REP assigns them the UDI Editor role in swissdamed’s UDI module. Foreign manufacturers cannot create a swissdamed account or register as economic operators in swissdamed’s Actors module.
The CH-REP is responsible for the integrity of all product data uploaded — verifying that registered product data is accurate, complete, and aligned with the mandate scope, both at initial registration and throughout the product lifecycle.
Immediate registration of the concerned medical device, IVD, System or Procedure Pack in swissdamed’s UDI module is required, before notification of the case to Swissmedic. The transition period that otherwise runs until 31 December 2026 does not apply to vigilance-triggered cases. Vigilance case notifications to Swissmedic cannot be submitted via swissdamed and must continue being submitted via e-mail.
We support investors and companies in merger and acquisition projects with regulatory risk assessments and expert insights.
Compliant solutions for regulatory challenges with medical software.
We support you in implementing the new regulatory requirements on time and in a structured way.
Overcome regulatory hurdles more efficiently and securely with us.
Transform your algorithm into a CE-certified medical device software in less than a year.
Get a solid starting position that saves you time in your project and supports you heading in the right direction.
Make your technical documentation compliant with tailored gap analyses, rapid feedback and compilation support.
Gain clarity with expert opinions on your compliance questions and assumptions to prevent misinterpretation.
You will receive regular updates around regulation of medical devices.
