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 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«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 a report on Swiss hospital inspections: Potential for improvement in hospitals (2023).
Swissmedic’s new forms published:
Swissmedic has published a list of corrections to the Good Practices for Reprocessing Units at hospitals, GPA Korrigendum (available only in DE, FR, IT).
European Commission
New guidance document MDCG 2024-12: Guidance and templates for Notified Body’s CAPA plans. Not relevant for economic operators.
New guidance document MDCG 2024-11: Guidance on qualification of IVDs. This document should be read in conjunction with the Manual on Borderline and Classification under the EU MDR & IVDR (v.3, Sep. 2023)
Reg. (I) 2024/2625 (IVDR) HS for aseptic processing of health care products and clinical performance studies using specimens from human subjects
Reg. (I) 2024/2631 (MDR) HS for aseptic processing of health care products
Team NB
Press Release – Transition to Implementation of Class D oversight by EURLs
European Commission
An updated version of guidance document MDCG 2021-4 (rev.1) on the application of transitional provision for Class D IVDs has been published, with the following changes:
Swissmedic
A letter has been sent by Swissmedic to Swiss Authorized Representatives and Swiss importers with the request to review devices that comply with the old legislation (MDD/AIMDD).
This entails making sure by 26-Sep-2024 that evidence of compliant “legacy” status is available in the form of the manufacturer’s self-declaration under EU MDR Art. 120(3c) and the Notified Body’s confirmation letter.
Swissmedic
Swissmedic has published a report on Swiss hospital inspections: Potential for improvement in hospitals (2023).
Swissmedic’s new forms published:
Swissmedic has published a list of corrections to the Good Practices for Reprocessing Units at hospitals, GPA Korrigendum (available only in DE, FR, IT).
European Commission
New guidance document MDCG 2024-12: Guidance and templates for Notified Body’s CAPA plans. Not relevant for economic operators.
New guidance document MDCG 2024-11: Guidance on qualification of IVDs. This document should be read in conjunction with the Manual on Borderline and Classification under the EU MDR & IVDR (v.3, Sep. 2023)
Reg. (I) 2024/2625 (IVDR) HS for aseptic processing of health care products and clinical performance studies using specimens from human subjects
Reg. (I) 2024/2631 (MDR) HS for aseptic processing of health care products
Team NB
Press Release – Transition to Implementation of Class D oversight by EURLs
You will receive regular updates around regulation of medical devices.
