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We simplify market access for medical devices

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.

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One partner for your medical device compliance

Obtain CE mark with proven experts

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.

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CE-certified medical device software

Transform 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.

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Swiss Authorised Representative

As 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.

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Compliance for Swiss medical device importers

We 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.

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Swissmedic: Inspection of importers

In 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.

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100+ 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.

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Regulatory Affairs News

10.07.2025

European Commission

 

Newly published MDCG 2025-7 on timelines for implementing “Master UDI-DI”:

 

The General-Purpose AI Code of Practice , as a voluntary tool for GPAI providers in support of compliance with the EU AI Act is now available.

  • Three chapters:
    • Transparency
    • Copyright
    • Safety and Security

 

Commission implementing Decision (EU) 2025/1324 related to expert panels under the EU MDR:

  • It provides some clarification regarding workload, common rules, travel expenses, etc.

 

Swissmedic

 

New information published on Swissmedic’s website regarding the ongoing consultation of the new version of the Swiss Good Reprocessing Practices for medical devices in outpatient facilities (GPA-ambulant). It is available in German,  French, and Italian only.

03.07.2025

Swissmedic

 

Some new versions of information sheets are published:

Information sheet on Products without an intended medical purpose (v.1.3): some minor wording changes.

 

Information sheet on Injectable products for wrinkle treatment (v.3.2): identical content to the previous version.

 

Team NB:

 

Position paper on Software Qualification under IVDR:

  • Intended to provide clarification on the expectations of the Notified Bodies and aligned with MDCG 2019-11
  • Illustrative software qualification examples (incl. AI-enabled software and accessories). Particular attention is recommended for mobile apps that analyze trends, provide clinical recommendations or send alerts based on IVD results (e.g. blood glucose), as these would correspond to IVD MDSW.
  • Decision steps with flowchart are introduced, beyond those in MDCG 2019-11.
26.06.2025

European Commission

 

Newly published Implementing Regulation (EU) 2025/1234, amending Reg. (EU) 2021/2226 on e-IFU for medical devices. 

It introduces the following key changes:

  • Extends the scope to all devices intended for use by professional users only
  • However, paper IFUs must be provided if there is any reasonably foreseeable use by lay persons.
  • Includes “Annex XVI products” 
  • Excludes accessories from the definition of a “fixed installed device”
  • Repeals Article 8, which previously mandated Notified Body involvement in e-IFU review
10.07.2025

European Commission

 

Newly published MDCG 2025-7 on timelines for implementing “Master UDI-DI”:

 

The General-Purpose AI Code of Practice , as a voluntary tool for GPAI providers in support of compliance with the EU AI Act is now available.

  • Three chapters:
    • Transparency
    • Copyright
    • Safety and Security

 

Commission implementing Decision (EU) 2025/1324 related to expert panels under the EU MDR:

  • It provides some clarification regarding workload, common rules, travel expenses, etc.

 

Swissmedic

 

New information published on Swissmedic’s website regarding the ongoing consultation of the new version of the Swiss Good Reprocessing Practices for medical devices in outpatient facilities (GPA-ambulant). It is available in German,  French, and Italian only.

03.07.2025

Swissmedic

 

Some new versions of information sheets are published:

Information sheet on Products without an intended medical purpose (v.1.3): some minor wording changes.

 

Information sheet on Injectable products for wrinkle treatment (v.3.2): identical content to the previous version.

 

Team NB:

 

Position paper on Software Qualification under IVDR:

  • Intended to provide clarification on the expectations of the Notified Bodies and aligned with MDCG 2019-11
  • Illustrative software qualification examples (incl. AI-enabled software and accessories). Particular attention is recommended for mobile apps that analyze trends, provide clinical recommendations or send alerts based on IVD results (e.g. blood glucose), as these would correspond to IVD MDSW.
  • Decision steps with flowchart are introduced, beyond those in MDCG 2019-11.

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