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MDR Documentation Submissions - BSI Group

MDR Documentation Submissions Revision 2, May 2020 Page 1 of 41 ` MDR Documentation Submissions Best Practices Guidelines MDR Documentation Submissions Revision 2, May 2020 Page 2 of 41 Contents 1 Introduction .. 3 2 Submission and Technical Documentation contents .. 3 Cover letter .. 3 The Technical Documentation .. 4 2. 3 Authorisation for the work to be conducted .. 4 3 Submission Method .. 4 4 Document Format .. 5 Language .. 5 Electronic File Format .. 5 Format and file size limits .. 5 Optical Character Recognition (searchable format) .. 6 Bookmarks .. 6 Signatures .. 7 5 Submission process.

6.4 Certificate scope ... interest in speeding up the review of Technical Documentation (as part of initial approvals, substantial ... Part E – Benefit-Risk Analysis and Risk Management Annex II Section 5 Section 4.2 Part 5 Part F – Pre-clinical Information

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