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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

10.10.2024

Swissmedic

 

Swissmedic has published a report on Swiss hospital inspections: Potential for improvement in hospitals (2023).

  • In 2023, Swissmedic inspected 25 hospitals:
    • Reprocessing in the reprocessing units for medical devices – 55% deviation
    • Endoscopy – critical deviation: lack of process validation
    • Maintenance – lack of systematic maintenance, deficiencies in cybersecurity related processes and interfaces, and deficiencies in risk management
    • Vigilance – poor process for processing Field Safety Notices
  • Swissmedic intends to reinforce controls and share best practice guidelines to improve compliance at Swiss hospitals.

 

Swissmedic’s new forms published:

 

Swissmedic has published a list of corrections to the Good Practices for Reprocessing Units at hospitals,  GPA Korrigendum (available only in DE, FR, IT).

 

European Commission

 

New guidance document MDCG 2024-12: Guidance and templates for Notified Body’s CAPA plans. Not relevant for economic operators.

  • Guidance for assessment bodies, notified bodies, designating authorities, and joint assessment teams to operate within the EU MDR and IVDR.
  • Annex I – CAPA template
  • Annex II – Joint Assessment Team (JAT) review template

 

New guidance document MDCG 2024-11: Guidance on qualification of IVDs. This document should be read in conjunction with the Manual on Borderline and Classification under the EU MDR & IVDR (v.3, Sep. 2023)

  • The new MDCG document provides guidance on qualification of IVDs and IVD accessories.
  • For IVD software, the guidance document just points to MDCG 2019-11.
  • Clarification on special cases (e.g. research-use only products, general laboratory use products, combinations of products, culture media, stains), as well as on particular uses (e.g. law enforcement).

 

Reg. (I) 2024/2625 (IVDR) HS for aseptic processing of health care products and clinical performance studies using specimens from human subjects

  • EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements
  • EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
  • These newly harmonised standards are consolidated in the Summary list

 

Reg. (I) 2024/2631 (MDR) HS for aseptic processing of health care products

  • EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements
  • This newly harmonised standard is consolidated in the Summary list

 

03.10.2024

Team NB

 

Press Release – Transition to Implementation of Class D oversight by EURLs

  • For IVDs with existing IVDR certificates or IVDR certification applications received before 2024-10-01: performance verification activities via EU Reference Laboratories (EURL) will be conducted before recertification.
  • For IVDs with new applications after 2024-10-01: performance verification activities via EURL will be part of the initial conformity assessment, before issuing the certificate.

 

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.

 

10.10.2024

Swissmedic

 

Swissmedic has published a report on Swiss hospital inspections: Potential for improvement in hospitals (2023).

  • In 2023, Swissmedic inspected 25 hospitals:
    • Reprocessing in the reprocessing units for medical devices – 55% deviation
    • Endoscopy – critical deviation: lack of process validation
    • Maintenance – lack of systematic maintenance, deficiencies in cybersecurity related processes and interfaces, and deficiencies in risk management
    • Vigilance – poor process for processing Field Safety Notices
  • Swissmedic intends to reinforce controls and share best practice guidelines to improve compliance at Swiss hospitals.

 

Swissmedic’s new forms published:

 

Swissmedic has published a list of corrections to the Good Practices for Reprocessing Units at hospitals,  GPA Korrigendum (available only in DE, FR, IT).

 

European Commission

 

New guidance document MDCG 2024-12: Guidance and templates for Notified Body’s CAPA plans. Not relevant for economic operators.

  • Guidance for assessment bodies, notified bodies, designating authorities, and joint assessment teams to operate within the EU MDR and IVDR.
  • Annex I – CAPA template
  • Annex II – Joint Assessment Team (JAT) review template

 

New guidance document MDCG 2024-11: Guidance on qualification of IVDs. This document should be read in conjunction with the Manual on Borderline and Classification under the EU MDR & IVDR (v.3, Sep. 2023)

  • The new MDCG document provides guidance on qualification of IVDs and IVD accessories.
  • For IVD software, the guidance document just points to MDCG 2019-11.
  • Clarification on special cases (e.g. research-use only products, general laboratory use products, combinations of products, culture media, stains), as well as on particular uses (e.g. law enforcement).

 

Reg. (I) 2024/2625 (IVDR) HS for aseptic processing of health care products and clinical performance studies using specimens from human subjects

  • EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements
  • EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
  • These newly harmonised standards are consolidated in the Summary list

 

Reg. (I) 2024/2631 (MDR) HS for aseptic processing of health care products

  • EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements
  • This newly harmonised standard is consolidated in the Summary list

 

03.10.2024

Team NB

 

Press Release – Transition to Implementation of Class D oversight by EURLs

  • For IVDs with existing IVDR certificates or IVDR certification applications received before 2024-10-01: performance verification activities via EU Reference Laboratories (EURL) will be conducted before recertification.
  • For IVDs with new applications after 2024-10-01: performance verification activities via EURL will be part of the initial conformity assessment, before issuing the certificate.

 

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