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

20.06.2024

European Commission

Updated MDCG 2022-13 (rev.1) on the designation, re-assessment and notification of NBs. The changes include:

  • Guidance on the conduct of joint assessments relating to extending the scope of designations
  • Revised Section 4.4 to Decision on granting the extension of the scope of designation
  • New section 5 Changes to a NB’s designation other than extension of its scope.
  • New section 6 Re-assessments of NBs.

 

SCHEER updated guidelines on phthalates published on 14-Jun-2024.

  • Referring to new guideline documents
  • Adapting recent regulatory developments
  • Extended annexes (Annex 8, 9, 10)

 

Swissmedic

Swissmedic updated its Guidance document on Incident economic operators v3.3, with the following changes:

  • Explicitly indicated that guidance document MDCG 2023-3 on Vigilance applies also in Switzerland and that, by analogy, the requirements also apply to IVDs.
  • Restructured section 9 on the reporting procedure so that subsection 9.1 corresponds to MIR, and added section 9.1.1 on the investigation by the manufacturer or System and Procedure Pack Producer (SPPP).
  • Restructured section 10 on the reports from end users that are forwarded to the manufacturer/SPPP by Swissmedic. Added subsection 10.2 on Swissmedic’s expectations on the manufacturer/SPPP justification of why the incident is not reportable.
13.06.2024

European Commission

Published MDCG 2024-1-5 Device-specific Vigilance Guidance (DVSG) no. 05 on Urogynaecological Surgical Mesh Implants: Guidance for manufacturers on reporting device-specific serious incidents, trend reports, and periodic summary reports for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.

 

Swissmedic

The below-amended ordinances relating to the Human Research Act (HRA, SR 810.30) were approved by the Swiss Federal Council on 7 June 2024 and shall apply as of 1 November 2024, except the provisions on transparency, which enter into force on 1 March 2025. These ordinances concern human research conducted in Switzerland.

  • Clinical Trials Ordinance (ClinO, SR 810.305)
  • Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306)
  • Human Research Ordinance (HRO, SR 810.301)
  • HRA Organisation Ordinance (OrgO-HRA, SR 810.308)

 

Swissmedic’s annual report for 2023:

  • General information on Medicinal Products in Switzerland
  • General information on Medical Devices in Switzerland
06.06.2024

Swissmedic

Updated Information Sheet on Clinical investigations with medical devices v4.4

  • Annex 2 updated according to MDCG 2024-3

Updated Information Sheet on Performance studies with IVD v3.5

  • MDCG 2020-10 replaced by MDCG 2024-4
  • Annex A2 updated according to MDCG 2024-3.

 

European Commission

Publication of the Implementing Decision C(2024)3371 amending Implementing Decision C(2021) 2406 on a standardisation request for Electrotechnical Standardization.

The details of what is being amended are described in Annexes I through III and include:

  • the lists of Harmonised Standards (HS) under the EU MDR and IVDR to be reviewed or drafted by CEN/CENELEC, and the corresponding deadlines,
  • some additions/modifications to the requirements for certain standards, e.g. the request for a new EU-REP symbol (instead of EC-REP) in EN ISO 15223-1.
20.06.2024

European Commission

Updated MDCG 2022-13 (rev.1) on the designation, re-assessment and notification of NBs. The changes include:

  • Guidance on the conduct of joint assessments relating to extending the scope of designations
  • Revised Section 4.4 to Decision on granting the extension of the scope of designation
  • New section 5 Changes to a NB’s designation other than extension of its scope.
  • New section 6 Re-assessments of NBs.

 

SCHEER updated guidelines on phthalates published on 14-Jun-2024.

  • Referring to new guideline documents
  • Adapting recent regulatory developments
  • Extended annexes (Annex 8, 9, 10)

 

Swissmedic

Swissmedic updated its Guidance document on Incident economic operators v3.3, with the following changes:

  • Explicitly indicated that guidance document MDCG 2023-3 on Vigilance applies also in Switzerland and that, by analogy, the requirements also apply to IVDs.
  • Restructured section 9 on the reporting procedure so that subsection 9.1 corresponds to MIR, and added section 9.1.1 on the investigation by the manufacturer or System and Procedure Pack Producer (SPPP).
  • Restructured section 10 on the reports from end users that are forwarded to the manufacturer/SPPP by Swissmedic. Added subsection 10.2 on Swissmedic’s expectations on the manufacturer/SPPP justification of why the incident is not reportable.
13.06.2024

European Commission

Published MDCG 2024-1-5 Device-specific Vigilance Guidance (DVSG) no. 05 on Urogynaecological Surgical Mesh Implants: Guidance for manufacturers on reporting device-specific serious incidents, trend reports, and periodic summary reports for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.

 

Swissmedic

The below-amended ordinances relating to the Human Research Act (HRA, SR 810.30) were approved by the Swiss Federal Council on 7 June 2024 and shall apply as of 1 November 2024, except the provisions on transparency, which enter into force on 1 March 2025. These ordinances concern human research conducted in Switzerland.

  • Clinical Trials Ordinance (ClinO, SR 810.305)
  • Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306)
  • Human Research Ordinance (HRO, SR 810.301)
  • HRA Organisation Ordinance (OrgO-HRA, SR 810.308)

 

Swissmedic’s annual report for 2023:

  • General information on Medicinal Products in Switzerland
  • General information on Medical Devices in Switzerland

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