The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter as regards the following:
(a) harmonised electronic forms for the application for clinical investigations and their assessment as referred to in and , taking into account specific categories or groups of devices; (b) the functioning of the electronic system referred to in ; (c) harmonised electronic forms for the notification of PMCF investigations as referred to in , and of substantial modifications as referred to in ; (d) the exchange of information between Member States as referred to in ; (e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in ; (f) the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in ; (g) uniform application of the requirements regarding the clinical evidence or data needed to demonstrate compliance with the general safety and performance requirements set out in . The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in .
