Our proven experts guide you through medical device CE certification. You gain hands-on support in regulatory affairs and quality management, ensuring regulatory compliance. Plus, as a Swiss Authorised Representative, we facilitate your access to the medical device market in Switzerland.
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 servicesTransform your algorithm into a CE-certified medical device software in less than a year. Decomplix, with its partner platform Evidencio, can offer a fast, proven, de-risked solution.
More about our medical device software serviceAs 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 serviceIn 2025, Swissmedic will inspect Swiss importers of medical devices for compliance with the MedDO and IvDO. Our experts will prepare you efficiently for the inspection so that you do not risk any interruption to your business.
More about our inspection readiness check100+ 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«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.»
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»
«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»
«It feels very good to have Decomplix as CH-REP.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»
«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.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«For our digital health initiatives, we feel we are in safe hands with 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.»
«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.»
«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.»
Swissmedic
Swissmedic has published an updated version of their Swiss guide for manufacturer’s MIR. This new version introduces significant content and structural changes on how to complete the new MIR form v. 7.3.1.
European Commission
MDCG 2025-8 Guidance on implementation of the Master UDI-DI was published.Â
EUDAMED Mandatory Use Postponement: The EU Commission’s Decision (EU) 2025/2371 on the functionality and the fulfilment of the functional specifications of EUDAMED has been published in the OJEU of 27 November 2025. It officially declares the functionality of EUDAMED’s first 4 modules (Actor, Vigilance, Clinical Investigation/Performance Studies, and Certificates).
In accordance with the transitional provisions in Reg. (EU) 2024/1860, these 4 modules will become mandatory 6 months after this publication, i.e. as from 28 May 2026.Â
Swissmedic has not yet reacted to this postponement, however, it is expected that the mandatory use of swissdamed’s UDI module will be postponed accordingly.Â
Swissmedic
The swissdamed Playground is now available. This platform allows economic operators to practice registering users, submitting data, and familiarizing themselves with the system before the mandatory go-live. A User Guide for the Playground has also been published.
Swissmedic
Updated Information Sheet on Export Certificates (v.3.10 of 11-Nov-2025). The changes include:
EU Commission
On 19 November 2025, the EU Commission published the Digital Omnibus package that encompasses targeted simplification measures on the implementation of certain EU AI Act’s provisions. Among them, a proposal to postpone the application date for high-risk AI systems per Annex I from August 2027 to August 2028.
Team-NB
New template agreement form to be used by incoming and outgoing Notified Bodies for the transfer of EU MDR formal application and of appropriate surveillance of legacy devices, specifying the terms of the transfer in respect of legacy devices covered by Directives certificates.
Swissmedic
Swissmedic has published an updated version of their Swiss guide for manufacturer’s MIR. This new version introduces significant content and structural changes on how to complete the new MIR form v. 7.3.1.
European Commission
MDCG 2025-8 Guidance on implementation of the Master UDI-DI was published.Â
EUDAMED Mandatory Use Postponement: The EU Commission’s Decision (EU) 2025/2371 on the functionality and the fulfilment of the functional specifications of EUDAMED has been published in the OJEU of 27 November 2025. It officially declares the functionality of EUDAMED’s first 4 modules (Actor, Vigilance, Clinical Investigation/Performance Studies, and Certificates).
In accordance with the transitional provisions in Reg. (EU) 2024/1860, these 4 modules will become mandatory 6 months after this publication, i.e. as from 28 May 2026.Â
Swissmedic has not yet reacted to this postponement, however, it is expected that the mandatory use of swissdamed’s UDI module will be postponed accordingly.Â
Swissmedic
The swissdamed Playground is now available. This platform allows economic operators to practice registering users, submitting data, and familiarizing themselves with the system before the mandatory go-live. A User Guide for the Playground has also been published.
You will receive regular updates around regulation of medical devices.
