Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by means of EUDAMED…
