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{"sheet":"1 - Einleitung-Ausfüllhinweise","index":0,"n_rows":10,"n_cols":2,"rows_kept":10,"cut":false,"hidden":false,"merged":[[3,0,3,1]]}
[]
["Einleitung"]
[null,"Dieses Formblatt dient der Erfassung aller zu bescheinigenden Produkte  und deren Varianten. \nAuf Grundlage dieser Informationen wird eingeschätzt:\n  - ob das angefragte Verfahren im Rahmen der Benennung nach MDR durchgeführt werden darf;\n  - ob in der SLG ausreichend und geeignete Ressourcen verfügbar sind.\n Fehler oder Ungenauigkeiten können Auswirkungen auf die Ergebnisse der Antragsprüfung haben oder zu Mehraufwand führen. "]
["==> Seien Sie entsprechend sorgfältig in Ihren Angaben."]
[]
["Ausfüllhinweise"]
[null,"- Beachten Sie alle Tabellenblätter, füllen Sie diese der Reihe nach aus."]
[null,"- Es sind nur Medizinprodukte oder Zubehör anzuführen, für die Sie Hersteller sind und das CE-Zeichen vergeben."]
[null,"- Beachten Sie die Kommentare mit den Ausfüllhinweisen an den Feldern."]
[null,"- Drop-Down-Auswahlfelder sollen eine Unterstützung sein. Überschreiben Sie den Wert, wo erforderlich."]

{"sheet":"2 - Allgemeine Angaben","index":1,"n_rows":14,"n_cols":3,"rows_kept":14,"cut":false,"hidden":false,"merged":[]}
[]
["Wird abgetötetes tierisches Gewebe eingesetzt? ",null,{"$f":"IF(B2=\"nein\", FALSE,TRUE)","v":true}]
["Geht ein pharmakologisch wirkender Stoff in ein Produkt ein?",null,{"$f":"IF(B3=\"nein\", FALSE,TRUE)","v":true}]
["Gehen Derivate von menschlichen Geweben oder Zellen ein?",null,true]
["Sind Vitro-Diagnostika enthalten?",null,true]
["Sind stoffliche oder absorbierbare Medizinprodukte enthalten?",null,true]
["Umfasst das Produkt Nano-Materialien?",null,true]
["Umfasst die eigene Produktpalette sterile Produkte?",null,true]
["Umfasst die eigene Produktpalette wiederverwendbare chirurgische Instrumente?",null,true]
["Umfasst die eigene Produktpalette nichtaktive Produkte?",null,true]
["Sind Produkte nach MDR, Anhang XVI, Abschnitt 1./2./3. oder 4. enhalten?",null,true]
["Ihr Unternehmen ist ein SME/ KMU3 nach 2003/361/EG?",null,true]
[]
[null,{"$f":"IF(OR($C$2,$C$3,$C$4,$C$5,$C$6,$C$7,$C$8,$C$9,$C$10,$C$11,NOT($C$12)),\"Wir können leider kein Verfahren anbieten, oder es wurden noch nicht alle Fragen beantwortet.\", \"Wir können ein Verfahren anbieten.\")","v":"Wir können leider kein Verfahren anbieten, oder es wurden noch nicht alle Fragen beantwortet."},{"$f":"OR(C2,C3,C4,C5,C6,C7,C8,C9,C10,C11)","v":true}]

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[]
[null,"INFORMATIONEN ZUR PRODUKTPALETTE"]
[null,"Herstellername:"]
[null,"SRN:"]
[]
[null,"Produktart","BASIS-UDI-DI","Produktbezeichnung","Identifizierungsmerkmal/\nRevision der \nTechnischen Dokumentation","Zweckbestimmung","Indikationen/ \n(medizinisches) Einsatzgebiet","Produktkategorie \n(MDA Codes)1","EMDN Code2","Risikoklasse","Klassifizierungsregel","UDI-DI","Produktmodellbezeichnung","Artikelnummer/REF","Cybersecurity \nBewertungsmethode","maschinelles Lernen/ künstliche Intelligenz","Sind Produkte vor der Anwendung zu sterilisieren oder keimarm aufzubereiten?","Die Technische Dokumentation wurde unter Nutzung von KI-Technologien erstellt?","Zertifizierungsstatus des Herstellers im Sinne der MDR"]
[]
[null,null,"alle Produkte"]
[1,"Medizinprodukt (MDR, Art.2, 1.) - BASIS-UDI",{"$f":"IF(ISNUMBER(SEARCH(\"UDI-DI\", $B9)), \"N/A\",\" \")","v":" "},{"$f":"IF(ISNUMBER(SEARCH(\"UDI-DI\", $B9)), \"N/A\",\" \")","v":" "}," "," "," "," "," "," "," "]
[2,null,{"$f":"IF(ISNUMBER(SEARCH(\"UDI-DI\", $B10)), \"N/A\",\" \")","v":" "}," "," "," "," "," "," "," "," "]
[3,null," "," "," "," "," "," "," "," "," "]
[4,null," "," "," "," "," "," "," "," "," "]
[5,null," "," "," "," "," "," "," "," "," "]
[6,null," "," "," "," "," "," "," "," "," "]
[7,null," "," "," "," "," "," "," "," "," "]
[8,null," "," "," "," "," "," "," "," "," "]
[9,null," "," "," "," "," "," "," "," "," "]
[10,null," "," "," "," "," "," "," "," "," "]
[11,null," "," "," "," "," "," "," "," "," "]
[12,null," "," "," "," "," "," "," "," "," "]
[13,null," "," "," "," "," "," "," "," "," "]
[14,null," "," "," "," "," "," "," "," "," "]
[15,null," "," "," "," "," "," "," "," "," "]
[16,null," "," "," "," "," "," "," "," "," "]
[17,null," "," "," "," "," "," "," "," "," "]
[18,null," "," "," "," "," "," "," "," "," "]
[19,null," "," "," "," "," "," "," "," "," "]
[20,null," "," "," "," "," "," "," "," "," "]
["x",null," "," "," "," "," "," "," "," "," "]

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["EIGENES BLATT FÜR KONFORMITÄTSRELEVANTE DIENSTLEISTER"]
[]
[]
["Bei ausgelagerten Prozessen\n(sofern für das Produkt konformitätsrelevant)"]
["Beschreibung:\nkonformitätsrelevante Dienstleister (cruSub - crucial Subcontractor)\nEs sind alle Unterauftragnehmer anzugeben, deren Tätigkeit produktkonformitätsbestimmend ist. \nkonformitätsrelevante Lieferanten (criSup - critical Supplier)\nEs sind solche Lieferanten aufzunehmen, bei denen Produkteigenschaften nicht über bekannte, vorzugsweise normative Spezifikationen bestimmt sind und wo die Eignung der beschafften Produkte sich nicht über Beschaffungsvorgaben und Fertigungskontrollen bestätigen lässt.",null,null,null,"Anmerkung:\nDiese Angaben sind wesentlich zur Einschätzugn des erwarteten Kontrollaufwandes im angefragten Verfahren.\n\n"]
["BASIS-UDI-DI","Typ","Name Dienstleister/ Lieferant","Adresse Dienstleister/ Lieferant","Tätigkeiten/Materialien/Komponenten","Akzeptanzkriterium/ Art der Kontrolle "]
["alle Produkte"]

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["Ergänzende Informationen"]
[]
["Produktkategorie (MD Codes)1","https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32017R2185&from=EN",null,null,null,null,null,"Auswahlfelder für Zertifizierungsverfahren"]
[null,"https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf",null,null,null,null,null,"neues Produkt"]
[null,"https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=321000",null,null,null,null,null,"neues Produkt, gültige Bescheinigung nach MDR, Anhang X"]
[null,null,null,null,null,null,null,"bescheinigt durch andere Stelle nach MDD, Anwendung der Übergangsfrist nach (EU) 2023/607"]
[null,"Aktuelle Codes im Benennungsumfang der SLG Prüf- und Zertifizierungs GmbH",null,null,null,null,null,"bescheinigt durch andere Stelle nach MDR, Übernahme durch die SLG"]
[null,"MDA 0201"]
[null,"MDA 0203"]
[null,"MDA 0204"]
[null,"MDA 0302"]
[null,"MDA 0303",null,null,null,null,null,"Auswahlfelder Dienstleister"]
[null,"MDA 0305",null,null,null,null,null,"cruSub"]
[null,"MDA 0307",null,null,null,null,null,"criSup"]
[null,"MDA 0308"]
[null,"MDA 0309",null,null,null,null,null,"Cybersecurity"]
[null,"MDA 0312",null,null,null,null,null,"nicht relevant "]
[null,"MDA 0313",null,null,null,null,null,"Anwendung IEC 81001-5-1"]
[null,"MDA 0315",null,null,null,null,null,"bewertet nach Team-NB Empfehlung"]
[null,"MDA 0316",null,null,null,null,null,"andere, bitte präzisieren"]
[null,"MDA 0318"]
[]
["EMDN Code2","https://webgate.ec.europa.eu/dyna2/emdn/",null,null,null,null,null,"TD - KI-Technologie"]
[null,"https://health.ec.europa.eu/system/files/2021-06/md_2021-12_en_0.pdf",null,null,null,null,null,"nein"]
[null,null,null,null,null,null,null,"zur Recherche - manuelle Verifizierung/Validierung Ergebnisse"]
["SME/ KMU3","https://single-market-economy.ec.europa.eu/smes/sme-fundamentals/sme-definition_en",null,null,null,null,null,"KI generierte Inhalte - Methodenvalidierung  "]
[]
[]
[null,null,null,null,null,null,null,"Produktart"]
[null,null,null,null,null,null,null,"Medizinprodukt (MDR, Art.2, 1.) - BASIS-UDI"]
[null,null,null,null,null,null,null,"Produktvariante zum Medizinprodukt - UDI-DI"]