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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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

16.05.2024

Swissmedic

Swissmedic is grouping all information on clinical investigations (under the MedDO) and performance studies (under the IvDO) on an overarching webpage for Clinical Trials. The webpage includes an Announcement section, where the latest news concerns the application of MDCG 2024-4 for reporting serious adverse events during performance studies in Switzerland.

Swissmedic has published an updated version of its Checklist for Inspection of Medical Device Reprocessing Services (v.1.2 of 1-May-2024), available only in German and French.

 

European Commission

4 new MDCG templates have been published, for the assessment and re-assessment of Notified Bodies by the corresponding Designating Authority:

  • MDCG 2024-6 on the preliminary re-assessment under the EU MDR
  • MDCG 2024-7 on the preliminary assessment under the EU MDR
  • MDCG 2024-8 on the preliminary assessment under the IVDR
  • MDCG 2024-9 on the preliminary re-assessment under the IVDR
02.05.2024

Switzerland

Swiss Medical Device Ordinance (SR 812.213) MedDO applies to products without intended medical purpose listed in Annex 1 of the MedDO (so-called “Annex XVI products”, by reference to the respective EU MDR annex) from 1-May-2024.

This date is almost one year later than the date of application of the EU MDR to Annex XVI products, i.e. 22-Jun-2023, because Switzerland implemented the requirements and transitional provisions with some delay, in the revision of the MedDO published on 1-Nov-2023.

However, the transitional periods in the MedDO are aligned with those in the EU MDR, i.e. 31-Dec-2029 if the devices have ongoing/planned clinical investigations or 31-Dec-2028 if they do not.

Products not marketed in Switzerland by 1-May-2024 cannot benefit from the transitional provisions.

Learn more about the situation of Annex XVI products in Switzerland from Swissmedic’s dedicated website.

25.04.2024

Swissmedic

Updated FSCA form (MU680_21_019, v.2.3), with the following changes:

  • On page 1: added field to indicate the expected date of the next FSCA report.
  • On page 5: grouped all options for actions to be taken on the same page (in the previous version, the option “None” was not readily visible).
  • On page 6: improved the buttons to add and remove sub-actions.
  • On page 7: in the list of countries affected, separated CH and LI, for clarity.
  • On page 7: added the following line to the final statement “the FSN to be published complies with data protection regulations” (see below information on data protection).

Communication sent by Swissmedic to Swiss economic operators via e-mail on 25-Apr-2024 requesting that, for data protection purposes, Field Safety Notices (FSN) do not include:

  • Personal data (e.g. names, personalized e-mail addresses, personal telephone numbers, signatures, etc.). Instead, generic e-mail addresses (e.g. info@company.com) or generic contact details (e.g. customer service) should be used.
  • Customers’ details.

 

Swiss MedTech

Guidance on placing of “legacy” devices on the Swiss market after 26 May 2024 published on 25-Apr-2024. Intended for Swiss importers, distributors, and manufacturers, the guideline helps clarify that “legacy” devices CE-marked under the MDD/AIMDD that will not be transitioning to the EU MDR, can no longer be “placed on the market” after 26 May 2024. It also provides details on the risks for certain specific cases, like consignment warehouses or MDSW made available via online web shops.

16.05.2024

Swissmedic

Swissmedic is grouping all information on clinical investigations (under the MedDO) and performance studies (under the IvDO) on an overarching webpage for Clinical Trials. The webpage includes an Announcement section, where the latest news concerns the application of MDCG 2024-4 for reporting serious adverse events during performance studies in Switzerland.

Swissmedic has published an updated version of its Checklist for Inspection of Medical Device Reprocessing Services (v.1.2 of 1-May-2024), available only in German and French.

 

European Commission

4 new MDCG templates have been published, for the assessment and re-assessment of Notified Bodies by the corresponding Designating Authority:

  • MDCG 2024-6 on the preliminary re-assessment under the EU MDR
  • MDCG 2024-7 on the preliminary assessment under the EU MDR
  • MDCG 2024-8 on the preliminary assessment under the IVDR
  • MDCG 2024-9 on the preliminary re-assessment under the IVDR
02.05.2024

Switzerland

Swiss Medical Device Ordinance (SR 812.213) MedDO applies to products without intended medical purpose listed in Annex 1 of the MedDO (so-called “Annex XVI products”, by reference to the respective EU MDR annex) from 1-May-2024.

This date is almost one year later than the date of application of the EU MDR to Annex XVI products, i.e. 22-Jun-2023, because Switzerland implemented the requirements and transitional provisions with some delay, in the revision of the MedDO published on 1-Nov-2023.

However, the transitional periods in the MedDO are aligned with those in the EU MDR, i.e. 31-Dec-2029 if the devices have ongoing/planned clinical investigations or 31-Dec-2028 if they do not.

Products not marketed in Switzerland by 1-May-2024 cannot benefit from the transitional provisions.

Learn more about the situation of Annex XVI products in Switzerland from Swissmedic’s dedicated website.

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