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Clinical Investigation Report in case of temporary halt



  • Anon
    19/05/2020 11:18
    Hi All, I have a question related to MDR Article 77 point 5. This states that irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV. In case of a temporary halt, the sponsor still has the intention to re-start the study. So do you really need to submit the report within 3 months? Potentially the sponsor can still take a decision to resume the investigation after e.g. 4 months but still have to submit a report after 3 months? Is this correct? Many thanks
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