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Recital 69

Recital 69

(69)Sponsors should report certain adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted. Member States should have the possibility of terminating or suspending the investigations or revoking the authorisation for those investigations, if considered necessary to ensure a high level of protection of the subjects participating in a clinical investigation. Such information should be communicated to the other Member States.

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