IVDR Article 77 — Implementing acts

Article 77

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 performance studies and their assessment as referred to in Articles 66 and 74, taking into account specific categories or groups of devices;

(b)

the functioning of the electronic system referred to in Article 69;

(c)

harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of substantial modifications as referred to in Article 71;

(d)

the exchange of information between Member States as referred to in Article 72;

(e)

harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76;

(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 76;

(g)

uniform application of the requirements regarding the clinical evidence/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 107(3).

This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.

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