Amendment 265 — European Parliament Mandate

**Target:** Proposal for a regulation — Article 9 — paragraph 2 — point c

## Text proposed by the Commission

(c) evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;

(c)

(c)

## Amendment of the European Parliament

(c) evaluation of emerging significant risks as described in point (a) and identified based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;

evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;

evaluation of emerging significant risks as described in point (a) and identified based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;