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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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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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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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Transform your algorithm into a CE-certified medical device software in less than a year. Decomplix, with its partner platform Evidencio, can offer a fast, proven, de-risked solution.

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Regulatory Affairs News

13.02.2025

European Commission

 

Updated MDCG 2019-6 rev.5, Q&A on the requirements relating to Notified Bodies

  • I.5.2 newly added to clarify the requirements of personnel responsible for conformity assessment.
  • I.6.1, I.6.2 & I.6.3 replace I.6, clarifying consultancy and training activities by Notified Bodies. “Structured dialogue” is clarified and examples are given.
  • I.9: updated, removed the last paragraph which involves the consultancy topic.
  • IV.1: updated, adding reference to new question IV.13 and EU MDR Art.120(3) & IVDR Art.110(3).
  • IV.7: updated, Notified Body’s allocation of resources must be clearly documented.
  • IV.10: updated, adding more clarification on the teamline of surveillance audits.
  • IV.12: updated, clarification on re-certifications, that are not repetitions of initial certifications.
    • Product certification: focus on clinical data from PMS and PMCF activities, and appropriate updates to the CERs.
    • QMS certification: check the audit programme and sampling plan are up to date or need adjustment. 
    • For both cases: CAPA should be followed up or closed, restricted if scope is to be adjusted, verify specific conditions or limitations, impose new conditions.
  • IV.13: newly added, clarify “leveraging evidence”. 

 

Swiss Federal Council

 

Switzerland announced on 12-Feb-2025 its ratification of the Council of Europe’s framework convention on artificial intelligence. 

  • The decision stems from the long-awaited outlook of future AI legislation that supports a sectoral implementation of AI rules in Switzerland. 
  • The next step is a consultation draft, due by the end of 2026, on the implementation of the CoE’s Convention in Switzerland, particularly in the areas of transparency, data protection, non-discrimination, and supervision. 
  • For AI in MedTech, the Swiss Federal Office of Public Health (FOPH) is preparing a report on the impact, and the need for amendments to the affected legislation.

 

This means that Switzerland will not be adopting the EU AI Act as is, at least not in the foreseeable future. Amendments to the MedDO/IvDO to align with AI rules could be expected at the earliest by 2027. However, this regulatory approach may be affected by the evolution of the Mutual Recognition Agreement between Switzerland and the EU.

06.02.2025

European Commission

 

MDCG has published an update to their ongoing/planned guidance development and deliverables of MDCG Subgroups (January 2025). Important changes:

  • The targeted review of MDCG 2019-11, the new guidance on PMS, as well as the reviewed MIR forms and related documents are now due in Q1 2025.
  • The long-awaited guidance on the interplay between the AI Act and EU MDR/IVDR is now due in Q2 2025.

 

A series of MDCG documents relative to EMDN codes have been either newly published or updated:

  • New MDCG 2025-1, EMDN ad-hoc procedure form, for the submission of EMDN code update proposals.
  • New MDCG 2025-2, summary of EMDN submissions in 2024 and outcome of the annual revision, including justification for those that were not accepted.
  • New MDCG 2025-3, Excel table with EMDN change history for 2024.
  • Updated MDCG 2024-2 rev.1, on the procedures for EMDN code updates, with an added table that aligns with newly published template form for submissions.
  • Updated MDCG 2021-12 rev.1, FAQ on the EMDN. Changes include:
    • Restructuring of questions into clear categories,
    • Additional new questions #7 – #10, on EMDN assignment,
    • Additional new questions #11 – #24, related to the annual review procedure.

 

In support of a down-classification of Covid tests, the EMA has published an Advice on SARS-CoV-2 on request from the MDCG confirming that SARS-CoV-2 no longer poses a life-threatening risk with a significant mortality rate for the general European population.

  • MDCG 2020-16 on IVD classification is being updated to reflect this scientific advice.

 

New Implementing Reg. (EU) 2025/117 on the procedures for joint scientific consultations on Health Technology Assessments (HTA) relative to medical devices and IVDs, which shall come into force on 12 February 2025. It describes:

  • The submission process (via HTA IT platform) and timelines.
  • The information exchange between HTA, JSC Subgroup (subgroup on joint scientific consultations of the Coordination Group) and EMA, as well as the selection and involvement of the experts.
  • The Briefing Package required (which includes a list of questions, and requesting a meeting is possible). A specific briefing package template for parallel consultations shall be established by the Coordination Group, in consultation with the EMA and expert panels.

 

Swissmedic

 

New revision of the FAQ on in vitro diagnostic medical device notifications (v.2.1)

  • Updates for notification of IVDs manufactured and used within a healthcare institution (in-house): the requirements set out in Art. 5 para. 5 let. d IVDR for in-house IVDs are to be applied from 31 December 2030. 

 

Revision of the Information Sheet on the submission of MIR by economic operators (v3.4)

  • Update to refer to the latest revision of MDCG 2023-3 on Vigilance, and extension of its applicability to IVDs, according to IvDO.

 

Updated documents relative to medical device maintenance, intended for healthcare institutions: 

30.01.2025

European Commission

 

MDCG has published an update to their ongoing/planned guidance development and deliverables of MDCG Subgroups (January 2025). Important changes:

  • The targeted review of MDCG 2019-11, the new guidance on PMS, as well as the reviewed MIR forms and related documents are now due in Q1 2025.
  • The long-awaited guidance on the interplay between the AI Act and EU MDR/IVDR is now due in Q2 2025.

 

A series of MDCG documents relative to EMDN codes have been either newly published or updated:

  • New MDCG 2025-1, EMDN ad-hoc procedure form, for the submission of EMDN code update proposals.
  • New MDCG 2025-2, summary of EMDN submissions in 2024 and outcome of the annual revision, including justification for those that were not accepted.
  • New MDCG 2025-3, Excel table with EMDN change history for 2024.
  • Updated MDCG 2024-2 rev.1, on the procedures for EMDN code updates, with an added table that aligns with newly published template form for submissions.
  • Updated MDCG 2021-12 rev.1, FAQ on the EMDN. Changes include:
    • Restructuring of questions into clear categories,
    • Additional new questions #7 – #10, on EMDN assignment,
    • Additional new questions #11 – #24, related to the annual review procedure.

 

In support of a down-classification of Covid tests, the EMA has published an Advice on SARS-CoV-2 on request from the MDCG confirming that SARS-CoV-2 no longer poses a life-threatening risk with a significant mortality rate for the general European population.

  • MDCG 2020-16 on IVD classification is being updated to reflect this scientific advice.

 

New Implementing Reg. (EU) 2025/117 on the procedures for joint scientific consultations on Health Technology Assessments (HTA) relative to medical devices and IVDs, which shall come into force on 12 February 2025. It describes:

  • The submission process (via HTA IT platform) and timelines.
  • The information exchange between HTA, JSC Subgroup (subgroup on joint scientific consultations of the Coordination Group) and EMA, as well as the selection and involvement of the experts.
  • The Briefing Package required (which includes a list of questions, and requesting a meeting is possible). A specific briefing package template for parallel consultations shall be established by the Coordination Group, in consultation with the EMA and expert panels.

 

Swissmedic

 

New revision of the FAQ on in vitro diagnostic medical device notifications (v.2.1)

  • Updates for notification of IVDs manufactured and used within a healthcare institution (in-house): the requirements set out in Art. 5 para. 5 let. d IVDR for in-house IVDs are to be applied from 31 December 2030. 

 

Revision of the Information Sheet on the submission of MIR by economic operators (v3.4)

  • Update to refer to the latest revision of MDCG 2023-3 on Vigilance, and extension of its applicability to IVDs, according to IvDO.

 

Updated documents relative to medical device maintenance, intended for healthcare institutions: 

13.02.2025

European Commission

 

Updated MDCG 2019-6 rev.5, Q&A on the requirements relating to Notified Bodies

  • I.5.2 newly added to clarify the requirements of personnel responsible for conformity assessment.
  • I.6.1, I.6.2 & I.6.3 replace I.6, clarifying consultancy and training activities by Notified Bodies. “Structured dialogue” is clarified and examples are given.
  • I.9: updated, removed the last paragraph which involves the consultancy topic.
  • IV.1: updated, adding reference to new question IV.13 and EU MDR Art.120(3) & IVDR Art.110(3).
  • IV.7: updated, Notified Body’s allocation of resources must be clearly documented.
  • IV.10: updated, adding more clarification on the teamline of surveillance audits.
  • IV.12: updated, clarification on re-certifications, that are not repetitions of initial certifications.
    • Product certification: focus on clinical data from PMS and PMCF activities, and appropriate updates to the CERs.
    • QMS certification: check the audit programme and sampling plan are up to date or need adjustment. 
    • For both cases: CAPA should be followed up or closed, restricted if scope is to be adjusted, verify specific conditions or limitations, impose new conditions.
  • IV.13: newly added, clarify “leveraging evidence”. 

 

Swiss Federal Council

 

Switzerland announced on 12-Feb-2025 its ratification of the Council of Europe’s framework convention on artificial intelligence. 

  • The decision stems from the long-awaited outlook of future AI legislation that supports a sectoral implementation of AI rules in Switzerland. 
  • The next step is a consultation draft, due by the end of 2026, on the implementation of the CoE’s Convention in Switzerland, particularly in the areas of transparency, data protection, non-discrimination, and supervision. 
  • For AI in MedTech, the Swiss Federal Office of Public Health (FOPH) is preparing a report on the impact, and the need for amendments to the affected legislation.

 

This means that Switzerland will not be adopting the EU AI Act as is, at least not in the foreseeable future. Amendments to the MedDO/IvDO to align with AI rules could be expected at the earliest by 2027. However, this regulatory approach may be affected by the evolution of the Mutual Recognition Agreement between Switzerland and the EU.

06.02.2025

European Commission

 

MDCG has published an update to their ongoing/planned guidance development and deliverables of MDCG Subgroups (January 2025). Important changes:

  • The targeted review of MDCG 2019-11, the new guidance on PMS, as well as the reviewed MIR forms and related documents are now due in Q1 2025.
  • The long-awaited guidance on the interplay between the AI Act and EU MDR/IVDR is now due in Q2 2025.

 

A series of MDCG documents relative to EMDN codes have been either newly published or updated:

  • New MDCG 2025-1, EMDN ad-hoc procedure form, for the submission of EMDN code update proposals.
  • New MDCG 2025-2, summary of EMDN submissions in 2024 and outcome of the annual revision, including justification for those that were not accepted.
  • New MDCG 2025-3, Excel table with EMDN change history for 2024.
  • Updated MDCG 2024-2 rev.1, on the procedures for EMDN code updates, with an added table that aligns with newly published template form for submissions.
  • Updated MDCG 2021-12 rev.1, FAQ on the EMDN. Changes include:
    • Restructuring of questions into clear categories,
    • Additional new questions #7 – #10, on EMDN assignment,
    • Additional new questions #11 – #24, related to the annual review procedure.

 

In support of a down-classification of Covid tests, the EMA has published an Advice on SARS-CoV-2 on request from the MDCG confirming that SARS-CoV-2 no longer poses a life-threatening risk with a significant mortality rate for the general European population.

  • MDCG 2020-16 on IVD classification is being updated to reflect this scientific advice.

 

New Implementing Reg. (EU) 2025/117 on the procedures for joint scientific consultations on Health Technology Assessments (HTA) relative to medical devices and IVDs, which shall come into force on 12 February 2025. It describes:

  • The submission process (via HTA IT platform) and timelines.
  • The information exchange between HTA, JSC Subgroup (subgroup on joint scientific consultations of the Coordination Group) and EMA, as well as the selection and involvement of the experts.
  • The Briefing Package required (which includes a list of questions, and requesting a meeting is possible). A specific briefing package template for parallel consultations shall be established by the Coordination Group, in consultation with the EMA and expert panels.

 

Swissmedic

 

New revision of the FAQ on in vitro diagnostic medical device notifications (v.2.1)

  • Updates for notification of IVDs manufactured and used within a healthcare institution (in-house): the requirements set out in Art. 5 para. 5 let. d IVDR for in-house IVDs are to be applied from 31 December 2030. 

 

Revision of the Information Sheet on the submission of MIR by economic operators (v3.4)

  • Update to refer to the latest revision of MDCG 2023-3 on Vigilance, and extension of its applicability to IVDs, according to IvDO.

 

Updated documents relative to medical device maintenance, intended for healthcare institutions: 

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