Article 81
Implementing acts
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 Articles 70 and78, taking into account specific categories or groups of devices; |
| (b) | the functioning of the electronic system referred to in Article 73; |
| (c) | harmonised electronic forms for the notification of PMCF investigations as referred to in Article 74(1), and of substantial modifications as referred to in Article 75; |
| (d) | the exchange of information between Member States as referred to in Article 76; |
| (e) | harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 80; |
| (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 Article 80; |
| (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 Annex I. |
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
