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NBOG Reports and News. Archive for previous NBOG Documents. The following documents have been withdrawn or replaced. NBOG’s Best Practice Guide. Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EECCertificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC. Notification form Directive 93/42/EEC. Notification form Directive 90/385/EEC. Notification form Directive 98/79/EC.
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NBOG Reports and News. Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten. Der Autor übernimmt keinerlei Gewähr für die Aktualität, Korrektheit, Vollständigkeit oder Qualität der bereitgestellten Informationen. Wir erklären hiermit ausdrücklich, dass zum Zeitpunkt der Linksetzung keine illegalen Inhalte auf den zu verlinkenden Seiten erkennbar waren. Auf die aktuelle und zukünftige Gestaltung, die Inhalte oder die Urheberschaft der gelinkten/verknüpften Seiten haben...
NBOG Reports and News - nbog.eu
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NBOG Reports and News. NBOG Reports and News. NBOG Report to MDEG 28 May 2015. FVO Joint Assessment Programme Final overview Report April 2015. NBOG Report to MDEG 17 November 2014. NBOG Report to MDEG 16 January 2014. NBOG Coordination Group Joint Assessment Programme Interim Overview Report. NBOG Coordination Group Summary Joint Assessment Programme. NBOG Report to MDEG 9 July 2013. NBOG Report to MDEG 14/15 January 2013. NBOG Meeting 3 February 2011. NBOG Report to MDEG November 2010.
NBOG Documents - nbog.eu
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NBOG Reports and News. In the light of NBOG’s terms of reference to identify and promulgate examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control NBOG has produced the following guideline:. New documents produced by NBOG will be published as documents of. NBOG’s Best Practice Guide. These documents provide guidance on specific aspects related to the activities of Notified Bodies. Guidance on Audit Report Content. Role of Noti...
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NBOG Reports and News. In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). This was in response to widespread concern that the performance of Notified Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent. Accordingly NBOG’s terms of reference were agreed to be:. NBOG is chaired by a representative of a Member State’s Competent Authority and hosted by the Commission&#...
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EAAR | Links
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European Commission Working Groups. European Commission, National Competent Authorities. European Commission Consumer Affairs Medical Devices. European Commission Consumer Affairs Medical Devices Legislation. European Commission Consumer Affairs Medical Devices Guidance Documents. European Commission Consumer Affairs Medical Devices Interpretative Documents. European Commission Consumer Affairs Medical Devices Consensus Statements. European Commission Consumer Affairs Medical Devices Borderline Documents.
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The new ISO 13485: the 2016 version. The official website of the European Commission. Http:/ ec.europa.eu/health/medical-devices. The portal to European Law. The official website of the European Union with links to the publications in the Official Journal. Http:/ eur-lex.europa.eu. The European Committee for. Http:/ www.cen.eu. The International Organization for. Http:/ www.iso.org. The European Committee for Electrotechnical Standardization. Http:/ www.cenelec.eu. Http:/ www.team-nb.org.
ecm - Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH, Aachen
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NBOG Reports and News. NBOG Reports and News. In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). This was in response to widespread concern that the performance of Notified Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent. Accordingly NBOG’s terms of reference were agreed to be:. NBOG is chaired by a representative of a Member State’s Competent Authority and hos...
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