Transcription of MDR Documentation Submissions - BSI Group
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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 .. 7 6 Additional topics to consider when preparing Technical Documentation for submission .. 9 Manufacturer personnel support .. 9 Document availability .. 9 Languages .. 9 Certificate scope .. 9 Subcontractors & Suppliers .. 9 Accessories .. 10 Novelty .. 10 ATTACHMENT A: Information to provide in a Technical Documentation submission.
MDR Documentation Submissions – Revision 2, May 2020 Page 5 of 41 4 Document Format 4.1 Language The official language of BSI is English, and all …
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