Article 5 · Commission Implementing Regulation (EU) 2026/977

Contents

Article 5Re-certification for product certificates#

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.

2.The notified body shall ensure that the documented procedures referred to in paragraph 1 require the manufacturer to provide also a list of changes to the approved device which are not yet notified and are necessary to:

(a)ensure the device complies with new regulatory requirements or new common specifications;

(b)take into consideration new scientific findings and new standards including harmonised standards, as referred to in Section 4.11, second paragraph, points (g) and (h) of Annex VII to Regulation (EU) 2017/745 or Section 4.11, second paragraph, points (g) and (h), of Annex VII to Regulation (EU) 2017/746, as applicable.

3.Where the changes referred to in paragraph 2 are necessary on the basis of new scientific findings, the manufacturer shall indicate, in the list referred to in that paragraph, if that basis is:

(a)new medical, scientific and technical knowledge, such as new medical procedures;

(b)new or revised testing methods of the properties and performances of the device;

(c)scientific findings on materials, including findings on their physical, chemical and microbiological characteristics and biocompatibility;

(d)results of clinical investigations or performance evaluations on equivalent devices and publicly available data from registers and registries.

4.The notified body shall assess the documentation referred to in paragraphs 1 and 2, received from the manufacturer, within 90 days at the maximum from the date of its receipt. As part of that assessment, the notified body shall:

(a)verify that the changes to the device are coherent with the information gathered from the post-market surveillance;

(b)verify that the changes to the device are coherent with the changes to the state of the art and the outcome of the updated risk analysis;

(c)verify that all non-compliances identified are either resolved or followed up by an adequate and accepted corrective actions and preventive actions plan within an appropriate period of time;

(d)where the certification was subject to conditions or limitations, verify whether those conditions or limitations are still valid, need to be amended or have become obsolete;

(e)verify whether the scope of the certificate needs to be amended;

(f)complete the final review referred to in Section 4.7 of Annex VII to Regulation (EU) 2017/745 or in Section 4.7 of Annex VII to Regulation (EU) 2017/746, as applicable.

5.If the notified body finds that the documentation received for the re-certification reviews is not sufficient to complete the assessment, it shall ask the manufacturer to provide clarification. Requests to provide additional technical documentation to that specified in paragraphs 1 and 2 shall be limited to the specific information necessary to complete the assessment.