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+ customers trust 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

26.09.2024

European Commission

 

An updated version of guidance document MDCG 2021-4 (rev.1) on the application of transitional provision for Class D IVDs has been published, with the following changes:

  • Question Q1 is obsolete, as it referred to applications lodged prior to 26-May-2022.
  • Questions Q2, Q4 and Q5 incorporate editorial or minor changes
  • Question Q3 is amended to introduce a reference to MDCG 2021-22 Rev 1 on what constitutes a “type of device”
  • Question Q6 on what would happen to certificates issued in the absence of EU Reference Laboratories (EURL) is reviewed. The provisions on consulting the EURL in case of changes shall apply if the initial performance verification by an EURL has been carried out.
  • New question Q7 on the date of application of the designation of EURLs (1-Oct-2024) is added. In particular for batch testing of Class D IVDs, as of 1 October 2024, Notified Bodies are obliged to engage with an appropriate EURL irrespective of whether an IVDR certificate has already been issued or is in preparation.

 

Swissmedic

 

A letter has been sent by Swissmedic to Swiss Authorized Representatives and Swiss importers with the request to review devices that comply with the old legislation (MDD/AIMDD).

This entails making sure by 26-Sep-2024 that evidence of compliant “legacy” status is available in the form of the manufacturer’s self-declaration under EU MDR Art. 120(3c) and the Notified Body’s confirmation letter.

 

05.09.2024

Swissmedic

 

The former Swissmedic’s InfoSheet on the Swiss Single Registration Number (CHRN) is now embedded in the form of a Q&A section, at the bottom of Swissmedic’s CHRN webpage.

29.08.2024

European Commission

 

Updated EU MDR – language requirements for manufacturers (Rev.1)

  • For France – documents for conformity assessment: addition of English (for certain parts)

 

Updated IVDR – national language requirements for manufacturers (Rev. 1)

  • For France – documents for conformity assessment: addition of English (for certain parts)
26.09.2024

European Commission

 

An updated version of guidance document MDCG 2021-4 (rev.1) on the application of transitional provision for Class D IVDs has been published, with the following changes:

  • Question Q1 is obsolete, as it referred to applications lodged prior to 26-May-2022.
  • Questions Q2, Q4 and Q5 incorporate editorial or minor changes
  • Question Q3 is amended to introduce a reference to MDCG 2021-22 Rev 1 on what constitutes a “type of device”
  • Question Q6 on what would happen to certificates issued in the absence of EU Reference Laboratories (EURL) is reviewed. The provisions on consulting the EURL in case of changes shall apply if the initial performance verification by an EURL has been carried out.
  • New question Q7 on the date of application of the designation of EURLs (1-Oct-2024) is added. In particular for batch testing of Class D IVDs, as of 1 October 2024, Notified Bodies are obliged to engage with an appropriate EURL irrespective of whether an IVDR certificate has already been issued or is in preparation.

 

Swissmedic

 

A letter has been sent by Swissmedic to Swiss Authorized Representatives and Swiss importers with the request to review devices that comply with the old legislation (MDD/AIMDD).

This entails making sure by 26-Sep-2024 that evidence of compliant “legacy” status is available in the form of the manufacturer’s self-declaration under EU MDR Art. 120(3c) and the Notified Body’s confirmation letter.

 

05.09.2024

Swissmedic

 

The former Swissmedic’s InfoSheet on the Swiss Single Registration Number (CHRN) is now embedded in the form of a Q&A section, at the bottom of Swissmedic’s CHRN webpage.

Latest from our blog