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Announcements

16.09.2024

New implementing regulations apply as of 1 November 2024

Swissmedic publishes instructions on the procedure for submitting applications

01.09.2024

Combined studies

New forms and a new information sheet for submissions to Swissmedic

01.07.2024

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Academic studies: Application for fee reduction

07.06.2024

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.

16.05.2024

Announcements on performance studies with vitro diagnostic medical devices

MDCG 2024-04 – New guidance document and table for safety reporting during performance studies.

27.01.2023

Announcements on clinical trials with medical devices

MDCG 2020-10 rev. 1 – The guidance document and table for safety reporting during clinical investigations have been updated.

27.01.2023

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Fee for the simplified review of clinical trials
Permanent link of this page
www.swissmedic.ch/
md-clinicaltrials-announcements-en

Important information

Swissmedic information sheets

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 31.10.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 731 kB, 31.10.2024)

BW600_00_017e_MB Combined studies (PDF, 348 kB, 31.10.2024)

Further links

Legal framework

List of ethics committees in Switzerland

Information and templates of the cantonal ethics committees

Overview of safety reporting to the Lead Ethics Committee and to Swissmedic

Guidance document of swissethics and Swissmedic on substantial modifications to clinical investigations of medical devices

Vigilance reporting in clinical trials of category A

Reporting incidents & FSCAs (vigilance)

Instructions

Login/Selbstregistrierung eGov Service eMessage

www.swissmedic.ch/emessage-de

eGOV Service eMessage

Support

Troubleshooting for PDF forms

Forms and templates

Forms for clincial inestigations of medical devices

BW610_10_021e_FO Authorisation clinical investigation MD (PDF, 1 MB, 01.11.2023)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 01.09.2022)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 01.10.2023)

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.11.2023)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.09.2022)

Forms for interventional performance studies with in vitro diagnostics

BW610_10_024e_FO Authorisation performance study IVD (PDF, 1 MB, 01.11.2023)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 01.10.2023)

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.11.2023)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 30.09.2022)

Forms for combined studies (a clinical trial of a medicinal product/ATMP conducted in parallel with a clinical trial of a medical device/IVD)

BW610_10_026e_FO Authorisation combined study IMP and MD (PDF, 1 MB, 01.09.2024)

BW610_10_027e_FO Authorisation combined study IMP and IVD (PDF, 1 MB, 01.09.2024)

BW610_20_025e_FO Form combined study MP/ATMP and MD/IVD Amendments, notifications, reports (PDF, 1 MB, 01.07.2024)

BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 01.09.2024)

General forms

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 01.07.2024)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2024)

Templates

BW610_10_030e_VL Application fee reduction selfdeclaration (DOCX, 366 kB, 01.07.2024)

MDCG 2020-10/2 - Safety reporting form for clinical investigations of medical devices

MDCG 2024-4 Appendix – Safety reporting form for IVD performance studies

MDCG 2021-8: Checklist of general safety and performance requirements, standards, common specifications and scientific advice

Checklist of general safety and performance requirements, standards, common specifications and scientific advice (IVDR) (DOCX, 70 kB, 26.05.2022)

BW610_10_056e_MB Example Statement of the manufacturer & documentation access confirmation (DOCX, 39 kB, 26.05.2022)

Legal basis

Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; SR 812.21)

Federal Act of 30 September 2011 on Research involving Human Beings (Human Research Act, HRA; SR 810.30)

Ordinance on Clinical Trials of Medical Devices (ClinO-MD; SR 810.306)

Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices (ClinO; SR 810.305)

Regulation (EU) 2017/745 on medical devices

Regulation (EU) 2017/746 on in-vitro diagnostic medical devices

EN ISO 14155 and other other European harmonized standards that establish the state of the art in science and technology of development and manufacture of medical devices: Source of supply

EU-Guidance-Documents

Last modification 16.10.2024

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