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Guidance for Declaration of Conformity Procedures

For Class I non-sterile non-measuring, Class 1 in vitro diagnostic (IVD) medical devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)

Self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.

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