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 â 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 â 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.»
European Commission
A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:
SCHEER
The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:
Swissmedic
New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation
EU-CH negotiations
Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:
Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.
European Commission
MDCG just published its MDCG guidance development plan for 2024
European Commission
Published updates to Harmonised Standards (HS):
MDCG 2024-3: Clinical Investigation Plan
This MDCG guidance document was already generically referenced in revision 1 of MDCG 2021-6 issued in December 2023. Another generic reference concerns an MDCG guidance document on the Investigatorâs Brochure, which is expected to be published soon.
Updates to the dashboard for Notified Body survey on certification and application (EU MDR/IVDR)
European Parliament
Artificial Intelligence Act adopted as Regulation on 13-Mar-2024:
MedTech Europe
Position paper regarding the Industry perspective on the final AI Act published on 13-Mar-2024. Main requests:
Proposal for âOne Substance, One Assessmentâ package published on 14-Mar-2024. Main aspects:
European Commission
A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:
SCHEER
The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:
Swissmedic
New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation
EU-CH negotiations
Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:
Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.
European Commission
MDCG just published its MDCG guidance development plan for 2024
You will receive regular updates around regulation of medical devices.
