Article 5, Paragraph 1. · Commission Implementing Regulation (EU) 2026/977

Contents

1.The notified body shall ensure that the documented procedures for the renewal of product certificates referred to in Section 4.11, second paragraph, of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, of Annex VII to Regulation (EU) 2017/746, as applicable, require the manufacturer to lodge an application for the re-certification reviews and to provide the following information from the initial certification or the last re-certification:

(a)a list that describes the changes, notified or not, referred to in Section 4.11, second paragraph, points (a) and (f), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, of Annex VII to Regulation (EU) 2017/746, as applicable, to the originally approved device, including those to the device requirements and the device components;

(b)the most recent periodic safety update report of the device and a summary of the field safety corrective actions taken on the device, following the experience from post-market surveillance referred to in Section 4.11, second paragraph, point (b), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, point (b), of Annex VII to Regulation (EU) 2017/746, as applicable;

(c)a summary of changes of the risk evaluation that resulted in a different benefit-risk ratio of a device, including those related to the field safety corrective actions taken following the experience from the risk management referred to in Section 4.11, second paragraph, point (c), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, point (c), of Annex VII to Regulation (EU) 2017/746, as applicable;

(d)identification of the changes made to the device to take into account the state of the art, following the experience referred to in Section 4.11, second paragraph, point (d), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, point (d), of Annex VII to Regulation (EU) 2017/746, as applicable;

(e)the most recent clinical evaluation report or performance evaluation report of the device, following the experience referred to in Section 4.11, second paragraph, point (e), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, point (e), of Annex VII to Regulation (EU) 2017/746, as applicable;

(f)identification of the changes referred to in Section 4.11, second paragraph, point (g), of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, point (g), of Annex VII to Regulation (EU) 2017/746, as applicable, made to the device.