MDR – Article 81 – Implementing acts

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).

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