We simplify market access for medical devices

Our proven experts guide you through the CE certification. You gain hands-on support in regulatory affairs and quality management, ensuring your compliance. Plus, as a Swiss Authorised Representative, we facilitate your market access in Switzerland.

100+ customers trust Decomplix

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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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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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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

23.11.2023

MedTech Europe/COCIR

16.11.2023

Swissmedic

BW690_00_001defi_FO Orders for export certificates for medical devices

  • New form version (v.1.3) for ordering of export certificates (Free Sales Certificates, FSC)
  • Watermark protection when uncompleted forms
  • No substantial changes

 

European Union

Reg. (EU) 2023/2482 amending REACH — Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:

  • 1 January 2029 as “Latest application date”
  • 1 July 2030 as the “Sunset date”, placing on the market and the use of the substance prohibited.
09.11.2023

MedTech Europe

Position paper – The Future of Europe’s Medical Technology Regulations

Ensuring efficiency, for example:

  • Considerably cut down on unnecessary bureaucracy in conformity assessment
  • Put in place a ‘pay for procedure’ model
  • Fully digitise the EU system
  • Permit digital labelling
  • More differentiation should be made between IVD class B and class C professional laboratory devices
  • Remove the limited validity of certificates

 

Embracing innovation, for example:

  • Early / pre-filing / pre-market dialogues
  • Create dedicated and accelerated assessment pathways
  • Improve the EU emergency use pathways
  • Adopt “pre-certification” access models
  • Adopt evidence requirements
  • Consider where devices can be brought through the European CE-marking system more quickly, based on regulatory
  • decisions taken by other jurisdictions

 

Effective governance, for example:

  • Taking system-level decisions
  • Driving a healthy ecosystem for medical technologies
  • Managing the decentralised network of Notified Bodies
  • Authoring guidance documents
  • Representing the system both within Europe and globally
  • Creating a structured, on-going stakeholder dialogue mechanism to identify needs for adapting the system
23.11.2023

MedTech Europe/COCIR

16.11.2023

Swissmedic

BW690_00_001defi_FO Orders for export certificates for medical devices

  • New form version (v.1.3) for ordering of export certificates (Free Sales Certificates, FSC)
  • Watermark protection when uncompleted forms
  • No substantial changes

 

European Union

Reg. (EU) 2023/2482 amending REACH — Amendments to Regulation (EC) No 1907/2006 concerning bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Changes of Article 1 with the following definitions:

  • 1 January 2029 as “Latest application date”
  • 1 July 2030 as the “Sunset date”, placing on the market and the use of the substance prohibited.

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