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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).

finding the report, confirming that the correct report has been found, confirming whether th ere have ... the Technical Documentation submitted, with components clearly labelled with name, lot number, expiry date and final draft IFU. On-goni g batch release w lli requrie, ni addtioi n to sendni g ktis to the EU Reference Laboratory as requried, ...

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