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Economic operators

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Reporting Incidents & FSCAs (Vigilance)

Last updated

June 3, 2024

Description

Learn about economic operators and their role in reporting incidents and FSCAs (vigilance).

Tags

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

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17 Main files

Wirtschaftsakteure

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/vorkommnisse---fsca-melden--materiovigilance-/hersteller---inverkehrbringer.html
Permalink: https://data.openrid.co/en/datasets/r/c6836017-e2e6-41e5-a331-b16ada9360ac
MIME Type: text/html

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

MU680_20_009d_WL Vorkommnis Wirtschaftsakteure

Updated on June 3, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009d_WL_Vorkommnis_Wirtschaftsakteure.pdf
Permalink: https://data.openrid.co/en/datasets/r/127fdb2f-71be-45a1-bd04-211083194363
MIME Type: application/pdf

Created on: June 3, 2024
Modified on: June 3, 2024

MU680_20_016e_FO Template: Manufacturer Incident Report (MIR)

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu680_20_016e_fo_meddev_template_manufacture_inciden_report.pdf.download.pdf/MU680_20_016e_FO_ext_Template_Manufacturer_Incident_Report.pdf
Permalink: https://data.openrid.co/en/datasets/r/1ea357f0-1851-483b-8330-1f2e08a43ffc
MIME Type: application/pdf

Created on: May 26, 2021
Modified on: May 26, 2021

MU680_20_013e_WL Help text new MIR

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/help_text.xlsx.download.xlsx/MU680_20_013e_WL%20Help%20text%20new%20MIR.xlsx
Permalink: https://data.openrid.co/en/datasets/r/7067192d-41e1-482f-8020-026721d1f4e5
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 26, 2021
Modified on: May 26, 2021

MU680_22_017e_FO Manufacturer’s Trend Report

Updated on October 10, 2023

docx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/meddev_template_trendreport.docx.download.docx/MU680_22_017e_FO%20Manufacturer%E2%80%99s%20Trend%20Report.docx
Permalink: https://data.openrid.co/en/datasets/r/c2f8c523-17f8-45af-a45b-6e507ebae1ba
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: October 10, 2023
Modified on: October 10, 2023

MU680_23_001e_FO Template Periodic Summary Report (PSR)

Updated on May 26, 2021

docx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/meddev_template_psr.docx.download.docx/MU680_23_001e_FO%20Template%20Periodic%20Summary%20Report%20(PSR).docx
Permalink: https://data.openrid.co/en/datasets/r/07d73224-67de-4ce4-87ef-ad9196241da4
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 26, 2021
Modified on: May 26, 2021

MU680_21_010d_WL FSCA Wirtschaftsakteure

Updated on July 18, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu680_21_010d_wl_mdv_fsca_hersteller_mepv.pdf.download.pdf/MU680_21_010d_WL%20FSCA%20Wirtschaftsakteure.pdf
Permalink: https://data.openrid.co/en/datasets/r/2fa7c089-c953-4f7c-b217-6b93ec4b8207
MIME Type: application/pdf

Created on: July 18, 2023
Modified on: July 18, 2023

MU680_21_019e_FO Field Safety Corrective Action (FSCA) Report

Updated on April 12, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu680_21_019e_fo_field_safety_corrective_action_report.pdf.download.pdf/MU680_21_019e_FO_ext_Template_FSCA_Report.pdf
Permalink: https://data.openrid.co/en/datasets/r/2e96bcb1-3a29-4d3c-8c42-440cc208c173
MIME Type: application/pdf

Created on: April 12, 2024
Modified on: April 12, 2024

Economic operators

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reporting-incidents---fscas/hersteller---inverkehrbringer.html
Permalink: https://data.openrid.co/en/datasets/r/714079f3-3360-412b-9e9b-339934e1e3ad
MIME Type: text/html

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

MU680_20_009e_WL Incident economic operators

Updated on June 3, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf
Permalink: https://data.openrid.co/en/datasets/r/2196b6b7-92ed-4876-bd57-40c97cd7f933
MIME Type: application/pdf

Created on: June 3, 2024
Modified on: June 3, 2024

MU680_21_010e_WL FSCA economic operators

Updated on July 18, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_21_010d_wl_mdv_fsca_hersteller_mepv.pdf.download.pdf/MU680_21_010e_WL%20FSCA%20economic%20operator.pdf
Permalink: https://data.openrid.co/en/datasets/r/d83989fa-58ba-4a52-bbb1-95330581ad59
MIME Type: application/pdf

Created on: July 18, 2023
Modified on: July 18, 2023

Operatori economici

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/it/home/dispositivi-medici/notificare-eventi---fsca/hersteller---inverkehrbringer.html
Permalink: https://data.openrid.co/en/datasets/r/8fa6ca5e-0a60-463c-85b4-1f68dc3013e3
MIME Type: text/html

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

MU680_20_009i_WL Incidente operatori economici

Updated on June 3, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009i_WL%20Incidente%20operatori%20economici.pdf
Permalink: https://data.openrid.co/en/datasets/r/6999a409-a882-496e-a23f-c25db88e659b
MIME Type: application/pdf

Created on: June 3, 2024
Modified on: June 3, 2024

MU680_21_010i_WL FSCA operatori economici

Updated on July 18, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/mu680_21_010d_wl_mdv_fsca_hersteller_mepv.pdf.download.pdf/MU680_21_010i_WL%20FSCA%20operatori%20economici.pdf
Permalink: https://data.openrid.co/en/datasets/r/023504e1-6573-4f94-b23e-12576c8c6477
MIME Type: application/pdf

Created on: July 18, 2023
Modified on: July 18, 2023

Opérateurs économiques

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/fr/home/dispositifs-medicaux/declaration-des-incidents---des-fsca/hersteller---inverkehrbringer.html
Permalink: https://data.openrid.co/en/datasets/r/f0d1897c-c38e-4706-8a02-90ccffe618da
MIME Type: text/html

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

MU680_20_009f_WL Incident opérateurs économiques

Updated on June 3, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009f_WL%20Incident%20op%C3%A9rateurs%20%C3%A9conomiques.pdf
Permalink: https://data.openrid.co/en/datasets/r/f270fed1-e5c9-406f-bb87-632e39c7e3ff
MIME Type: application/pdf

Created on: June 3, 2024
Modified on: June 3, 2024

MU680_21_010f_WL FSCA opérateurs économiques

Updated on July 18, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/mu680_21_010d_wl_mdv_fsca_hersteller_mepv.pdf.download.pdf/MU680_21_010f_WL%20FSCA%20op%C3%A9rateurs%20%C3%A9conomiques.pdf
Permalink: https://data.openrid.co/en/datasets/r/18d6a904-0af9-4223-8adf-e81ce306fe54
MIME Type: application/pdf

Created on: July 18, 2023
Modified on: July 18, 2023