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Designation_IVDR
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/746
List of In Vitro Diagnostic Medical Devices (IVDR)
Notification of Change (Regulation (EU) 2017/746)
Price List (Certification according to IVDR)
Questionnaire for a quotation – In-vitro Diagnostic Devices
Rules for certification procedures according to Regulation (EU) 2017/746
Technical Documentation (In-vitro Diagnostic Devices)
Technical Documentation (In-vitro Diagnostic Devices) – File Structure (ZIP)
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