Announcements

Name: Announcements
Creator: Swiss Agency for Therapeutic Products
Keywords: access,advice,amendments,applications,authorization,checklists,clinical-investigation,clinical-trials,common-specifications,examples,fees,forms,guidances,in-vitro-diagnostics,in-vitro-diagnostics-regulation,investigation,ivd,ivdr,manufacturers,measures,medical-devices,notification,performance,reduction,reporting,requirements,research,restrictions,review,safety,scientific,standards

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical Trials

Published

August 20, 2024

Last updated

August 20, 2024

Description

Various announcements on clinical trials, clinical investigation etc.

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

26 Main files

Mitteilungen

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/klinische-versuche/mitteilungen-klv-mep.html
Permalink: https://data.openrid.co/en/datasets/r/bb91af7a-286a-4f68-b107-72ff504b734b
MIME Type: text/html

Created on: September 6, 2023
Modified on: September 6, 2023

BW600_00_015e_MB Clinical investigations with medical devices

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw600_00_015d_mb_klinische_versuche_mep.pdf.download.pdf/BW600_00_015e_MB_Clinical_investigations_with_medical_devices.pdf
Permalink: https://data.openrid.co/en/datasets/r/68fc812c-2584-4ec7-963c-b1cc3e2713ab
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

BW600_00_016e_MB Performance studies with IVD

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf
Permalink: https://data.openrid.co/en/datasets/r/f8e41b11-d000-487c-8189-186c413e46c7
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

BW600_00_017e_MB Combined studies

Updated on August 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw600_00_017e_mb_combined_studies.pdf.download.pdf/BW600_00_017e_MB_Information_combined_studies_KlinV_KlinVMEP.pdf
Permalink: https://data.openrid.co/en/datasets/r/54882fdc-18bc-46c1-9429-d1aa304003b1
MIME Type: application/pdf

Created on: August 1, 2024
Modified on: August 1, 2024

BW610_10_021e_FO Authorisation clinical investigation MD

Updated on November 1, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw610_10_021d_foklinischeversuchemitmedizinproduktenbewilligungsgesuch.pdf.download.pdf/BW610_10_021e_FO_Authorisation_clinical_investigation_MD_KlinVMEP.pdf
Permalink: https://data.openrid.co/en/datasets/r/72db2501-ecdb-4d76-a097-3708a419273d
MIME Type: application/pdf

Created on: November 1, 2023
Modified on: November 1, 2023

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems

Updated on September 1, 2022

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw610_10_022d_fo_klinischeversuchemitforschungssequenzenaufce-markiertenmrisystemen.pdf.download.pdf/BW610_10_022e_FO_Research_sequences_CE-marked_MRI_systems_KlinVMEP.pdf
Permalink: https://data.openrid.co/en/datasets/r/9de91915-dcc5-4ea8-aad6-4579a22969ed
MIME Type: application/pdf

Created on: September 1, 2022
Modified on: September 1, 2022

See the 26 main files