Article 6, Paragraph 1. · Commission Implementing Regulation (EU) 2026/977

Contents

1.The notified body shall ensure that the documented procedures for the renewal of the quality management system certificates referred to in Section 4.11, first paragraph, of Annex VII to Regulation (EU) 2017/745 or Section 4.11, first paragraph, of Annex VII to Regulation (EU) 2017/746, as applicable, shall require the manufacturers to lodge an application for the re-certification and, within 90 days at the maximum from the date of receipt of such application, the notified body to:

(a)verify that all the relevant requirements for conducting audits provided for in Section 4.5.2 of Annex VII and Sections 2.2 and 2.3 of Annex IX to Regulation (EU) 2017/745 or in Section 4.5.2 of Annex VII and Sections 2.2 and 2.3 of Annex IX to Regulation (EU) 2017/746, as applicable, have been fully assessed at least once after the date of issuance of the certificates and before their expiry date;

(b)verify that the results of all surveillance activities carried out, announced or unannounced, in accordance with Section 4.10 of Annex VII to Regulation (EU) 2017/745 or with Section 4.10 of Annex VII to Regulation (EU) 2017/746, as applicable, during the certification cycle, especially on-site audits of the manufacturer, its subcontractors / suppliers, and product tests carried out, as well as the outcome of technical documentation assessments on a sampling basis, still comply with the relevant provisions of Regulation (EU) 2017/745 or Regulation (EU) 2017/746, as applicable;

(c)verify whether the audit programme and the sampling plan drawn up according to Section 4.5.2(a) of Annex VII to Regulation (EU) 2017/745 or according to Section 4.5.2(a) of Annex VII to Regulation (EU) 2017/746, as applicable, are still up to date or need to be amended;

(d)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;

(e)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;

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

(g)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.