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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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

15.02.2024

EUDAMED

EUDAMED User Guide and templates v. 2.14 updated:

UDI Devices Module

  • Certificate and SSCP/SSP information can be found in Basic UDI-DI section.
  • Bugs fixed

NB & Certificates Module

  • Newly added functions related to registering SSCP/SSP and linking Basic UDI-DI
  • Hyperlink of Basic UDI-DI from NB & Certificate module to UDI/Device module will be automatically updated
  • Indication the validation of the new SSCP/SSP master document is required (NB’s obligation)
  • Bugs fixed

Data Exchange

  • Include the information on inactivation of the SSCP/SSP and related certificates in the payload when downloading.
  • Bugs fixed

 

EU Health Technology Assessment (HTA)

Updated rolling plan for the implementation of Reg. (EU) 2021/2282 on HTA published on 6-Feb-2024.

Fifth information stakeholder event planned for 09-Apr-2024: From Theory to Practice – Implementing the EU HTA Regulation

Video recordings of the stakeholder event held on 30-Jan-2024 available from the event webpage: From Theory to Practice – Implementing the EU HTA Regulation

Topics discussed:

  • Understanding key elements of the EU HTA Regulation
  • Challenges and opportunities in the implementation process
  • Involving stakeholders in EU HTA implementation
08.02.2024

European Commission

MDCG 2024-2 Procedures for the updates of the EMDN:

  • The Nomenclature Working Group (NOM WG) is responsible for the use of EMDN
  • Annual revisions of the EMDN – 4 phases throughout the year
  • Expedited review for ad-hoc updates of the EMDN
  • platform for EMDN requests (visualization of existing EMDN codes less user-friendly than in previous website version)

 

Swissmedic

New timelines for swissdamed release:

  • Actor (ACT) module for registration of economic operators – 2nd half of 2024 (instead of 1Q2024)
  • UDI module to register devices – available 4 months after the ACT module’s go-live

 

Notified Body

BSI FAQs on EU MDR transition (new version)

  • Clarification on renewal of the old certificates, NB’s confirmation letters, NB transfers due to MDR transition, changes to “legacy devices”
  • Clarification of MDR application with BSI

Notified Bodies Survey on certifications and applications – Status Oct. 2023

  • Update status by October 2023
  • All NB surveys presented in The Dashboard

 

COCIR

Joint statement in support of the extension of e-IFU for medical devices (2-Feb-2024)

  • Proposal for an update to the scope of Reg. (EU) 2021/2226 for specific product categories
  • Highlights advantages of e-IFU for professional use
01.02.2024

European Commission

Published MDCGs for Device Specific Vigilance Guidances Templates:

  • A general explanation of the report criteria for serious incidence, PSR, and Trend Report
  • Guidance for reporting and IMDRF codes

MDCG 2024-1 Device Specific Vigilance Guidances (DSVG) Template

 

Swissmedic

Published checklist (available only in German and French) in support of the Swiss Guideline for the validation and routine monitoring of cleaning and disinfection processes for medical devices, intended as an aid for healthcare professionals who check the annual validation reports of instrument washer disinfectors and trolley washer-disinfectors.

15.02.2024

EUDAMED

EUDAMED User Guide and templates v. 2.14 updated:

UDI Devices Module

  • Certificate and SSCP/SSP information can be found in Basic UDI-DI section.
  • Bugs fixed

NB & Certificates Module

  • Newly added functions related to registering SSCP/SSP and linking Basic UDI-DI
  • Hyperlink of Basic UDI-DI from NB & Certificate module to UDI/Device module will be automatically updated
  • Indication the validation of the new SSCP/SSP master document is required (NB’s obligation)
  • Bugs fixed

Data Exchange

  • Include the information on inactivation of the SSCP/SSP and related certificates in the payload when downloading.
  • Bugs fixed

 

EU Health Technology Assessment (HTA)

Updated rolling plan for the implementation of Reg. (EU) 2021/2282 on HTA published on 6-Feb-2024.

Fifth information stakeholder event planned for 09-Apr-2024: From Theory to Practice – Implementing the EU HTA Regulation

Video recordings of the stakeholder event held on 30-Jan-2024 available from the event webpage: From Theory to Practice – Implementing the EU HTA Regulation

Topics discussed:

  • Understanding key elements of the EU HTA Regulation
  • Challenges and opportunities in the implementation process
  • Involving stakeholders in EU HTA implementation
08.02.2024

European Commission

MDCG 2024-2 Procedures for the updates of the EMDN:

  • The Nomenclature Working Group (NOM WG) is responsible for the use of EMDN
  • Annual revisions of the EMDN – 4 phases throughout the year
  • Expedited review for ad-hoc updates of the EMDN
  • platform for EMDN requests (visualization of existing EMDN codes less user-friendly than in previous website version)

 

Swissmedic

New timelines for swissdamed release:

  • Actor (ACT) module for registration of economic operators – 2nd half of 2024 (instead of 1Q2024)
  • UDI module to register devices – available 4 months after the ACT module’s go-live

 

Notified Body

BSI FAQs on EU MDR transition (new version)

  • Clarification on renewal of the old certificates, NB’s confirmation letters, NB transfers due to MDR transition, changes to “legacy devices”
  • Clarification of MDR application with BSI

Notified Bodies Survey on certifications and applications – Status Oct. 2023

  • Update status by October 2023
  • All NB surveys presented in The Dashboard

 

COCIR

Joint statement in support of the extension of e-IFU for medical devices (2-Feb-2024)

  • Proposal for an update to the scope of Reg. (EU) 2021/2226 for specific product categories
  • Highlights advantages of e-IFU for professional use

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