Technical File

Technical file remediation according to MDR or IVDR:

 

Remediation

Annex II – Technical documentation: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner.

Annex III – Technical documentation on post-market surveillance: The technical documentation on post-market surveillance to be drawn up by the manufacturer in accon  in a clear, organized, readily searchable and unambiguous manner.

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