Transcription of IVDR Documentation Submissions - BSI Group
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IVDR Documentation Submissions - BSI Group
IVD R Documentation Submissions R ev isio n 3, May 2020 Page 1 of 27 ivdr Documentation Submissions Best Practices Guidelines IVD R Documentation Submissions R ev isio n 3, May 2020 Page 2 of 27 Contents 1 Introduction ..3 2 Submission and technical Documentation Contents ..3 Cover Letter ..3 The technical Documentation ..4 Authorisation for Work to be Conducted ..4 3 Verificat ion of Performance ..4 Information Required to Support Verification of Manufactured Product (Class D O n ly) 4 4 Submission Method ..5 5 Document Language ..5 Electronic F ile Form at an d File S ize L im it 5 Optical Character Recognition (Searchable Format).
review of Technical Documentation (Summary of Technical Documentation (STED), initial application, renewal application, etc.) and reducing the time to certificate decision. The most frequent reasons for delays in the review of the Technical Documentation are:
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