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Announcements

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

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.
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, 775 kB, 27.12.2023)

BW600_00_016e_MB Performance studies with IVD (PDF, 745 kB, 27.12.2023)

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

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_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_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.09.2022)

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

Templates

MDCG 2020-10/2 Safety Report Form

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 with Medical Devices (ClinO-MD; SR 810.306)

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 27.01.2023

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