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    • July 18, 2024 at 2:29 pm #5168
      Katarzyna Lis
      Participant

      Hi All,

      where do you file:
      – manufacturers letters confirming that their devices for in-vitro diagnostics comply with Regulation 2017/746? I thought to place these in 08.01.02 Lab validation documentation.
      – certificates for CE marked devices and declaration of conformity documents as per REGULATION (EU) 2023/607. Does it belong to i.e. 06.05.01 NonIP supply plan?

      Thanks.

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