Matches in Data.gov.be for { <http://data.gov.be/.well-known/genid/97c111a523604f4dac6684a233a43a172-b1115> ?p ?o ?g. }
- 97c111a523604f4dac6684a233a43a172-b1115 accessRights PUBLIC @default.
- 97c111a523604f4dac6684a233a43a172-b1115 description "Das zentrale Rückverfolgbarkeitsregister wurde auf der Grundlage des Königlichen Erlasses vom 17.02.2015 geschaffen, mit dem das Gesetz vom 13.12.2013 über Medizinprodukte umgesetzt wird. Dieses Gesetz verpflichtet: a) Jeder Vertreiber von Medizinprodukten auf dem belgischen Markt, um seine Produkte bei der FAGG zu registrieren; b) Jeder Angehörige der Gesundheitsberufe in Belgien muss alle Implantationen und Explantationen von Medizinprodukten bei der FAGG registrieren. Das zentrale Rückverfolgbarkeitsregister erleichtert verschiedenen Interessenträgern: a) Pflegedienstleister können die Implantation oder Explantation registrieren und den Nachweis der Benachrichtigung des Verkäufers einsehen; b) Patienten können ihre Implantationen einsehen und eine Patientenkarte erstellen, die die wichtigsten Informationen über ihre Implantate enthält; c) FAGG-Agenten können eine anonymisierte Ansicht aller registrierten Implantationen und Explantationen einsehen; d) Der von der FAGG zugelassene Arzt kann alle registrierten Implantationen und Explantationen, einschließlich der NISS des Patienten, konsultieren." @default.
- 97c111a523604f4dac6684a233a43a172-b1115 description "Het centrale traceerbaarheidsregister is opgericht op basis van het koninklijk besluit van 17/02/2015, dat uitvoering geeft aan de wet van 13/12/2013 betreffende medische hulpmiddelen. Deze wet verplicht: a) elke distributeur van medische hulpmiddelen op de Belgische markt om zijn hulpmiddelen te registreren bij het FAGG; b) Elke gezondheidswerker in België registreert alle implantaties en explantaties van medische hulpmiddelen bij het FAGG. Het centrale traceerbaarheidsregister faciliteert verschillende belanghebbenden: a) Zorgverleners kunnen de implantatie of explantatie registreren en het bewijs van kennisgeving van de verkoper raadplegen; b) Patiënten kunnen hun implantaten raadplegen en een "patiëntkaart" aanmaken met de belangrijkste informatie over hun implantaten; c) FAGG-agenten kunnen een geanonimiseerde weergave van alle geregistreerde implantaties en explantaties raadplegen; d) de FAGG erkende arts kan alle geregistreerde implantaties en explantaties raadplegen, inclusief de NISS van de patiënt." @default.
- 97c111a523604f4dac6684a233a43a172-b1115 description "Le registre central de traçabilité a été créé sur la base de l'arrêté royal du 17/02/2015, qui exécute la loi du 13/12/2013 relative aux dispositifs médicaux. Cette loi oblige: a) Chaque distributeur de dispositifs médicaux sur le marché belge pour enregistrer ses dispositifs auprès de la FAGG; b) Chaque professionnel de santé en Belgique pour enregistrer toutes les implantations et explantations de dispositifs médicaux à la FAGG. Le registre central de traçabilité facilite les différentes parties prenantes: a) Les fournisseurs de soins peuvent enregistrer l'implantation ou l'explantation et consulter la preuve de notification du vendeur; b) les patients peuvent consulter leurs implantations et créer une «carte patient» contenant les informations clés sur leurs implants; c) les agents FAGG peuvent consulter une vue anonymisée de toutes les implantations et explantations enregistrées; d) le médecin autorisé par la FAGG peut consulter toutes les implantations et explantations enregistrées, y compris le NISS du patient." @default.
- 97c111a523604f4dac6684a233a43a172-b1115 description "The central traceability registry has been created based on the Royal Decree of 17/02/2015, which executes the law of 13/12/2013 regarding medical devices. This law obliges: a) Each distributor of medical devices on the Belgian market to register its devices at the FAGG; b) Each health professional in Belgium to register all implantations and explantations of medical devices at the FAGG. The central traceability registry facilitates different stakeholders: a) Care providers can register the implantation or explantation, and consult the proof of notification of the vendor; b) Patients can consult their implantations and can create a “patient card” containing the key information about their implants; c) FAGG agents can consult an anonymized view of all registered implantations and explantations; d) the FAGG authorised doctor can consult all registered implantations and explantations, including the NISS of the patient." @default.
- 97c111a523604f4dac6684a233a43a172-b1115 identifier "185b0a3e-b37d-4edb-a2ed-a658e71ebb75" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 language ENG @default.
- 97c111a523604f4dac6684a233a43a172-b1115 modified "2021-04-02" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 publisher 0884579424 @default.
- 97c111a523604f4dac6684a233a43a172-b1115 spatial 2802361 @default.
- 97c111a523604f4dac6684a233a43a172-b1115 title "Central Registry Traceability of Implants" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 title "Traceerbaarheid van implantaten in het centrale register" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 title "Traçabilité des implants dans le registre central" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 title "Zentrale Registerrückverfolgbarkeit von Implantaten" @default.
- 97c111a523604f4dac6684a233a43a172-b1115 type Dataset @default.
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