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.