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Archives:
Dokumente
Common Issues in the Submission of Technical Documentation for In Vitro Diagnostic Devices (IVDs)
March 27, 2025
Designation_MDR
March 5, 2025
Questionnaire for a quotation – In Vitro Diagnostic Medical Devices – Attachment: List of In Vitro Diagnostic Medical Devices (IVDR)
November 13, 2024
General Terms And Conditions – Seminars
November 13, 2024
List of Medical Devices (MDR)
November 13, 2024
List of critical suppliers / OEM-Manufacturers (DIR, standards)
November 13, 2024
Notification of Changes (MDD/IVDD)
October 31, 2024
Notification of Change (Regulation (EU) 2017/746)
October 31, 2024
Application for inspection of manufactured products according to annex IV.6 of Directive 98/79/EC
October 16, 2024
List of products – In-vitro Diagnostic Devices (CE 0483)
September 11, 2024
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