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.

100+ Kunden vertrauen Decomplix

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.

More about our CE mark services

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.

More about our CH-REP service

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.

More about our importers service

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.

Read more about us

Regulatory Affairs News

28.11.2024

European Commission

MDCG 2024-14 on the Master UDI-DI (MUDI) that replaces UDI-DI for standard contact lenses that share a combination of design parameters (at least base curve and diameter).

  • Terminology and conditions for the assignment of Master UDI-DI (MUDI) are introduced.
  • MUDI assignment shall apply from November 9th, 2025.
  • The rules for the UDI carrier apply to the MUDI. Requirements on labelling of contact lens blisters are dependent on space constraints. Higher levels of packaging shall have their own Master UDI-DI, if applicable.
  • EUDAMED registration with MUDI is clarified. Manufacturers should engage with an UDI issuing entity as soon as possible, and at least before the Vigilance and Post-Market Surveillance module of EUDAMED becomes mandatory.
  • Vigilance reporting shall provide MUDI and UDI-PI (EU MDR devices) in the reporting forms. For “legacy” contact lenses, Eudamed ID or UDI-DI shall be used in the reporting in EUDAMED.

 

21.11.2024

Swiss Federal Office of Public Health (FOPH)

In preparation of the upcoming amendments to the MedDO and IvDO, the below explanatory reports have been published. Draft versions of the amended MedDO and IvDO are not yet available.

  • Explanatory report – Adaptation of the transitional arrangements and addition of information on the authorised representative (German version; other languages available: French, Italian)
    • Adapting the update in Reg.(EU) 2024/1860, in regards of the IVDR extended transitional provision.
    • Article 87 (requiring CH-REP particulars on the label of IVDs not intended for self-test from 31-Mar-2025) will be withdrawn and replaced by the new Article 15 §9 that makes the exception permanent, i.e. CH-REP for IVDs not intended for self-test CE-marked under the IVDR can continue to be indicated on an accompanying document.
  • Explanatory Report − Product registration obligation (German version; other languages available: French, Italian)
    • Product registration in the UDI module of swissdamed shall become mandatory from 1-Jul-2026.
    • Registration period will run from 01-Jul-2026 through 31-Dec-2026.
    • Products to be registered:
      – All medical devices, systems and procedure packs, and IVDs placed on the Swiss market after 1-Jul-2026.
      – However, the CH-REP of foreign manufacturers and PP/System producers (or the Swiss manufacturer or PP/S producer) shall immediately register any EU MDR/IVDR-compliant products placed on the Swiss market from 26-Nov-2017 if a Vigilance case needs to be reported.
      – No product registration at all for “legacy” or “old” medical devices, systems / procedure packs, and IVDs.

CAREFUL! There is an important translation misalignment in the French version vs. the German/Italian versions:

  • DE/IT: “All products placed on the Swiss market after July 1st, 2026 must be registered in swissdamed, regardless of where the manufacturer is based.”
  • FR: “Manufacturers are required to register all devices they place on the Swiss market from 1 July 2026, regardless of where their headquarters are located.”

Decomplix considers the German version as reference. This means that it is not certain that registration of devices in swissdamed’s UDI module will be incumbent upon the foreign manufacturer. In fact, it seems unlikely that foreign manufacturers will be required to upload information in swissdamed given the fact that the CH-REP will be the entity responsible for registering products placed on the Swiss market prior to 1-Jul-2026 in case of Vigilance reporting.

Swissmedic

Updated information sheet on notification of devitalised human tissue (v2.1).

  • Correction of the reference to the announcement on changes to the Annexes to the Customs Treaty

 

European Commission

Q&A on Gradual Roll-out of EUDAMED

  • Q&A on all modules of the EUDAMED

 

14.11.2024

European Commission

Revised version of guidance document MDCG 2023-3 rev.1: Q&A on Vigilance

  • The contents have been expanded to cover IVDR requirements, too.
  • It brings clarification on “abnormal use” and “use errors due to ergonomic features” (in questions #5 & 6).
  • New questions have been added:
    • #8 on direct harm related to IVDs;
    • #9 on expected erroneous results, for IVDs;
    • #11 on the reportability of serious incidents with CE-marked devices used in a clinical investigation or performance study, and
    • #19 on CAPA to be notified to competent authorities, per EU MDR Art. 83(4) and IVDR Art. 78(4).
28.11.2024

European Commission

MDCG 2024-14 on the Master UDI-DI (MUDI) that replaces UDI-DI for standard contact lenses that share a combination of design parameters (at least base curve and diameter).

  • Terminology and conditions for the assignment of Master UDI-DI (MUDI) are introduced.
  • MUDI assignment shall apply from November 9th, 2025.
  • The rules for the UDI carrier apply to the MUDI. Requirements on labelling of contact lens blisters are dependent on space constraints. Higher levels of packaging shall have their own Master UDI-DI, if applicable.
  • EUDAMED registration with MUDI is clarified. Manufacturers should engage with an UDI issuing entity as soon as possible, and at least before the Vigilance and Post-Market Surveillance module of EUDAMED becomes mandatory.
  • Vigilance reporting shall provide MUDI and UDI-PI (EU MDR devices) in the reporting forms. For “legacy” contact lenses, Eudamed ID or UDI-DI shall be used in the reporting in EUDAMED.

 

21.11.2024

Swiss Federal Office of Public Health (FOPH)

In preparation of the upcoming amendments to the MedDO and IvDO, the below explanatory reports have been published. Draft versions of the amended MedDO and IvDO are not yet available.

  • Explanatory report – Adaptation of the transitional arrangements and addition of information on the authorised representative (German version; other languages available: French, Italian)
    • Adapting the update in Reg.(EU) 2024/1860, in regards of the IVDR extended transitional provision.
    • Article 87 (requiring CH-REP particulars on the label of IVDs not intended for self-test from 31-Mar-2025) will be withdrawn and replaced by the new Article 15 §9 that makes the exception permanent, i.e. CH-REP for IVDs not intended for self-test CE-marked under the IVDR can continue to be indicated on an accompanying document.
  • Explanatory Report − Product registration obligation (German version; other languages available: French, Italian)
    • Product registration in the UDI module of swissdamed shall become mandatory from 1-Jul-2026.
    • Registration period will run from 01-Jul-2026 through 31-Dec-2026.
    • Products to be registered:
      – All medical devices, systems and procedure packs, and IVDs placed on the Swiss market after 1-Jul-2026.
      – However, the CH-REP of foreign manufacturers and PP/System producers (or the Swiss manufacturer or PP/S producer) shall immediately register any EU MDR/IVDR-compliant products placed on the Swiss market from 26-Nov-2017 if a Vigilance case needs to be reported.
      – No product registration at all for “legacy” or “old” medical devices, systems / procedure packs, and IVDs.

CAREFUL! There is an important translation misalignment in the French version vs. the German/Italian versions:

  • DE/IT: “All products placed on the Swiss market after July 1st, 2026 must be registered in swissdamed, regardless of where the manufacturer is based.”
  • FR: “Manufacturers are required to register all devices they place on the Swiss market from 1 July 2026, regardless of where their headquarters are located.”

Decomplix considers the German version as reference. This means that it is not certain that registration of devices in swissdamed’s UDI module will be incumbent upon the foreign manufacturer. In fact, it seems unlikely that foreign manufacturers will be required to upload information in swissdamed given the fact that the CH-REP will be the entity responsible for registering products placed on the Swiss market prior to 1-Jul-2026 in case of Vigilance reporting.

Swissmedic

Updated information sheet on notification of devitalised human tissue (v2.1).

  • Correction of the reference to the announcement on changes to the Annexes to the Customs Treaty

 

European Commission

Q&A on Gradual Roll-out of EUDAMED

  • Q&A on all modules of the EUDAMED

 

Latest from our blog