Article

Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR)

Alternative solutions to submit and/or exchange information (as required under the IVDR)

Responsible actor(s)

Article 94: Good administrative practice

4. Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body of the measure taken.

Paragraph 4:Competent authorities should notify the relevant notified bodies and responsible authorities by means of e-mail. The information shared by electronic means should be encrypted whenever possible and deemed necessary.

Member states communication

Companies Get Alternative Options For IVDs Pending A Fully-Functional Eudamed

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