Article 2, Paragraph 2., Point (d) · Commission Implementing Regulation (EU) 2026/977

Contents

1. For the purposes of Section 4.5.1, second paragraph, third…
2. The notified body shall ensure that conformity assessment…
3. The notified body shall complete the assessment of a plann…
4. The notified body shall continue the conformity assessment…

(d)20 days for the decision and certification, starting on the day after the completion of the last relevant final review referred to in point (b) or (c), depending on the conformity assessment procedure requested, and ending on the day the certificates are issued and entered in the European database on medical devices (‘Eudamed’) in accordance with Section 4.8 of Annex VII to Regulation (EU) 2017/745 or Section 4.8 of Annex VII to Regulation (EU) 2017/746, as applicable.