Notification of medical devices

Name: Notification of medical devices
Creator: Swiss Agency for Therapeutic Products
Keywords: access,custom-made,custom-made-devices,guidances,markets,mdr,medical-devices,medical-devices-regulations,notification,procedures

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Market Access

Last updated

July 15, 2023

Description

Notification of medical devices for market access.

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

32 Main files

Meldung von Medizinprodukten

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/marktzugang/meldung-medizinprodukten.html
Permalink: https://data.openrid.co/en/datasets/r/031c9d46-63b9-449d-8a7f-2c07c0dca7dc
MIME Type: text/html

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

BW630_30_026d_FO Meldung nach Art. 19 MepV für Sonderanfertigungen

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_026d_fo_meldung_art-19_mepv_sonderanfertigungen.pdf.download.pdf/BW630_30_026d_FO_Sonderanfertigungen_MEP_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/7d3bf957-c7e1-474a-b031-db06f3126f50
MIME Type: application/pdf

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

BW630_30_025d_FO Meldung nach Art. 53 Abs. 4 und Art. 54 Abs. 4 MepV von umgepackten / umgekennzeichneten Medizinprodukten

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_025d_fo_meldung_umgepackten-umgekennzeichneten-mep.pdf.download.pdf/BW630_30_025d_FO%20umgepackte_umgekennzeichnete_MEP_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/76d7934f-7bc6-4561-bad7-4c1f6af1aa1b
MIME Type: application/pdf

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

Beispielliste Art. 53/54 MepV

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/beispielliste_umverpacker.xlsx.download.xlsx/Beispielliste_Umverpacker.xlsx
Permalink: https://data.openrid.co/en/datasets/r/aa83203e-4892-4af8-aa07-59b9c7ad84c8
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_027d_FO Meldung nach Art. 18 MepV für in Gesundheitseinrichtungen hergestellte Produkte

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_027d_fo_meldung_art-18_mepv_gesundheitseinrichtungen.pdf.download.pdf/BW630_30_027d_FO_In_Gesundheitseinrichtungen_hergestellte_MEP_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/a5f5e8ae-92cf-4f13-9a49-85a4e01e8a99
MIME Type: application/pdf

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

BW630_30_028d_FO Meldung nach Art. 108 MepV (Art. 6 aMepV) für Medizinprodukte und Systeme oder Behandlungseinheiten nach MDR

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_028d_fo_meldung_art-108_mepv_mdr.pdf.download.pdf/BW630_30_028d_FO%20Meldung%20nach%20Art.%20108%20MepV%20(Art.%206%20aMepV)%20f%C3%BCr%20Medizinprodukte%20und%20Systeme%20oder%20Behandlungseinheiten%20nach%20MDR.pdf
Permalink: https://data.openrid.co/en/datasets/r/80729d52-267c-45e0-95f3-5bdae15393f7
MIME Type: application/pdf

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

Beispielliste MDR

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/beispielliste_mdr.xlsx.download.xlsx/Beispielliste_MDR.xlsx
Permalink: https://data.openrid.co/en/datasets/r/1ca87818-255a-4a62-90ec-1b74e82f98e6
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_009d_MB FAQ Medizinprodukte Notifikationen

Updated on July 15, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009d_MB_FAQ_Notifikationen.pdf
Permalink: https://data.openrid.co/en/datasets/r/23c295d9-8992-4368-9ffd-2e6b5cf1c183
MIME Type: application/pdf

Created on: July 15, 2023
Modified on: July 15, 2023

Notification of medical devices

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/meldung-medizinprodukten.html
Permalink: https://data.openrid.co/en/datasets/r/507c089f-ec75-492a-90bc-4e38d7e7066f
MIME Type: text/html

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

BW630_30_026e_FO Notification in accordance with Art. 19 MedDO for custom-made devices

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_026d_fo_meldung_art-19_mepv_sonderanfertigungen.pdf.download.pdf/BW630_30_026e_FO_Custom_made_MD_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/2b9d1544-7ae2-4f20-82cc-34696f1590d5
MIME Type: application/pdf

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

BW630_30_025e_FO Notification in accordance with Art. 53 para. 4 and Art. 54 para. 4 MedDO of repackaged/relabelled medical devices

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_025d_fo_meldung_umgepackten-umgekennzeichneten-mep.pdf.download.pdf/BW630_30_025e_FO_Repackaged_relabelled_MD_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/d7f41149-a00e-44b0-9867-701c6adf1aef
MIME Type: application/pdf

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

Product list template Art. 53/54 MedDO

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/beispielliste_umverpacker.xlsx.download.xlsx/Beispielliste_Umverpacker.xlsx
Permalink: https://data.openrid.co/en/datasets/r/486766c8-27c3-49fd-ab73-caed368e51af
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_027e_FO Notification in accordance with Art. 18 MedDO for devices manufactured within health institutions

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_027d_fo_meldung_art-18_mepv_gesundheitseinrichtungen.pdf.download.pdf/BW630_30_027e_FO_MD_manufactured_in_health_institution_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/58c980df-8cec-440c-9b8d-89128b317c9f
MIME Type: application/pdf

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

BW630_30_028e_FO Notification according to art. 108 MedDO (art. 6 oMedDO) for medical devices and systems or procedure packs according to MDR

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_028d_fo_meldung_art-108_mepv_mdr.pdf.download.pdf/BW630_30_028e_FO%20Notification%20according%20to%20art.%20108%20MedDO%20(art.%206%20oMedDO)%20for%20medical%20devices%20and%20systems%20or%20procedure%20packs%20according%20to%20MDR.pdf
Permalink: https://data.openrid.co/en/datasets/r/f9ce5c40-944f-4374-9073-6952a005a375
MIME Type: application/pdf

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

Product list template MDR

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/beispielliste_mdr.xlsx.download.xlsx/Beispielliste_MDR.xlsx
Permalink: https://data.openrid.co/en/datasets/r/eb1dc96d-a1ea-4651-929b-5828fb483362
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_009e_MB FAQ Notifications

Updated on July 15, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf
Permalink: https://data.openrid.co/en/datasets/r/7365c26c-5c9a-4885-bb28-e6fad7fbff63
MIME Type: application/pdf

Created on: July 15, 2023
Modified on: July 15, 2023

Notifica di dispositivi medici

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/it/home/dispositivi-medici/accesso-al-mercato/meldung-medizinprodukten.html
Permalink: https://data.openrid.co/en/datasets/r/d45e13cb-1933-447a-a903-7affc6994248
MIME Type: text/html

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

BW630_30_026i_FO Notifica ai sensi dell’art. 19 ODmed per i dispositivi su misura

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw630_30_026d_fo_meldung_art-19_mepv_sonderanfertigungen.pdf.download.pdf/BW630_30_026i_FO_DM_su_misura_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/668135f6-49cc-4f0f-a3c0-71b031e05833
MIME Type: application/pdf

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

BW630_30_025i_FO Notifica ai sensi dell’art. 53 cpv. 4 e art. 54 cpv. 4 ODmed di dispositivi medici riconfezionati/rietichettati

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw630_30_025d_fo_meldung_umgepackten-umgekennzeichneten-mep.pdf.download.pdf/BW630_30_025i_FO_DM_riconfezionati_rietichettati_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/834e5473-1698-4ca5-bf80-64ae9662ce69
MIME Type: application/pdf

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

Modello per l’elenco Art. 53/54 ODmed

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/beispielliste_umverpacker.xlsx.download.xlsx/Beispielliste_Umverpacker.xlsx
Permalink: https://data.openrid.co/en/datasets/r/9786b10c-1e68-492f-8cbc-ab4bfdb7816e
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_027i_FO Notifica ai sensi dell’art. 18 ODmed di dispositivi fabbricati in istituzioni sanitarie

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw630_30_027d_fo_meldung_art-18_mepv_gesundheitseinrichtungen.pdf.download.pdf/BW630_30_027i_FO_DM_fabbricati_in_istituzioni_sanitarie_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/8bd6bc51-5ccb-4bc9-a672-bf87f1ff3cdf
MIME Type: application/pdf

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

BW630_30_028i_FO Notifica secondo l’art. 108 ODmed (art. 6 vODmed) per dispositivi medici di classe I e sistemi o kit procedurali ai sensi del MDR

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw630_30_028d_fo_meldung_art-108_mepv_mdr.pdf.download.pdf/BW630_30_028i_FO%20Notifica%20secondo%20l%E2%80%99art.%20108%20ODmed%20(art.%206%20vODmed)%20per%20dispositivi%20medici%20di%20classe%20I%20e%20sistemi%20o%20kit%20procedurali%20ai%20sensi%20del%20MDR.pdf
Permalink: https://data.openrid.co/en/datasets/r/14810898-b275-4a00-8ded-48e16ec445e9
MIME Type: application/pdf

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

Modello per l’elenco MDR

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/beispielliste_mdr.xlsx.download.xlsx/Beispielliste_MDR.xlsx
Permalink: https://data.openrid.co/en/datasets/r/c7c6d53f-0deb-4aa6-b303-cb72f2596593
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_009i_MB FAQ sulle notifiche

Updated on July 15, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009i_MB_FAQ_sulle_notifiche.pdf
Permalink: https://data.openrid.co/en/datasets/r/e1979ffb-9191-4a37-86ed-cff1790359e9
MIME Type: application/pdf

Created on: July 15, 2023
Modified on: July 15, 2023

Déclaration de dispositifs médicaux

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/fr/home/dispositifs-medicaux/acces-au-marche/meldung-medizinprodukten.html
Permalink: https://data.openrid.co/en/datasets/r/d6123b7b-0867-4ad9-961e-df786b360fd7
MIME Type: text/html

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

BW630_30_026f_FO Déclaration de dispositifs sur mesure selon l’art. 19 ODim

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/bw630_30_026d_fo_meldung_art-19_mepv_sonderanfertigungen.pdf.download.pdf/BW630_30_026f_FO_DM_sur_mesure_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/4afea221-2a0f-4ce4-8dd3-234ffbc2aab2
MIME Type: application/pdf

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

BW630_30_025f_FO Déclaration de dispositifs médicaux reconditionnés / réétiquetés selon l’art. 53, al. 4 et l’art. 54, al. 4 ODim

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/bw630_30_025d_fo_meldung_umgepackten-umgekennzeichneten-mep.pdf.download.pdf/BW630_30_025f_FO_DM_reconditionn%C3%A9s_r%C3%A9%C3%A9tiquet%C3%A9s_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/a30cec08-d9f5-454b-975d-440ac1c3f416
MIME Type: application/pdf

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

Modèle de liste Art. 53/54 ODim

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/beispielliste_umverpacker.xlsx.download.xlsx/Beispielliste_Umverpacker.xlsx
Permalink: https://data.openrid.co/en/datasets/r/8d7d90c2-aaf7-4f5c-bebd-624322858029
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_027f_FO Déclaration de dispositifs fabriqués dans un établissement de santé selon l’art. 18 ODim

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/bw630_30_027d_fo_meldung_art-18_mepv_gesundheitseinrichtungen.pdf.download.pdf/BW630_30_027f_FO_DM_fabriqu%C3%A9s_dans_%C3%A9tablissement_de_sant%C3%A9_MepV-%C3%84e.pdf
Permalink: https://data.openrid.co/en/datasets/r/5a67d9b9-d321-413b-b376-5b75279a1270
MIME Type: application/pdf

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

BW630_30_028f_FO Déclaration selon l’art. 108 ODim (art. 6 aODim) pour les dispositifs médicaux de classe I et les systèmes ou nécessaires selon le RDM

Updated on May 26, 2021

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/bw630_30_028d_fo_meldung_art-108_mepv_mdr.pdf.download.pdf/BW630_30_028f_FO%20D%C3%A9claration%20selon%20l%E2%80%99art.%20108%20ODim%20(art.%206%20aODim)%20pour%20les%20dispositifs%20m%C3%A9dicaux%20de%20classe%20I%20et%20les%20syst%C3%A8mes%20ou%20n%C3%A9cessaires%20selon%20le%20RDM.pdf
Permalink: https://data.openrid.co/en/datasets/r/fa96348e-0a88-4dc9-83ce-b3c9660005ea
MIME Type: application/pdf

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

Modèle de liste RDM

Updated on May 26, 2021

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/beispielliste_mdr.xlsx.download.xlsx/Beispielliste_MDR.xlsx
Permalink: https://data.openrid.co/en/datasets/r/e99bf795-d8f8-4a34-a858-b7fcba8bde38
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

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

BW630_30_009f_MB Questions fréquentes (FAQ) sur les notifications

Updated on July 15, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009f_MB_FAQ_sur_les_notifications.pdf
Permalink: https://data.openrid.co/en/datasets/r/9a9862d4-51eb-4d46-9840-4fa14d3c5ce1
MIME Type: application/pdf

Created on: July 15, 2023
Modified on: July 15, 2023

Notification of medical devices

Information

Type

Regulated products

Topics

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

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