Article 3 · Commission Implementing Regulation (EU) 2026/977

Contents

Article 3Interruption of timeline#

1.Where there is a need for a manufacturer to address non-compliances, or duly justified questions and requests from the notified body that are necessary for its assessment, the notified body may interrupt the timeline of the conformity assessment activities for a maximum of:

(a)one time for the phase referred to in Article 2(2), point (a);

(b)four times for the phase referred to in Article 2(2), point (b);

(c)four times for the phase referred to in Article 2(2), point (c);

(d)five times in total for the phases referred to in Article 2(3), points (a) and (b);

(e)three times in total for the reviews and verifications referred to in Articles 5 and 6;

(f)one time for the phase referred to in Article 2(2), point (d), Article 2(3), point (c), and Article 7(2), where the notified body asks the manufacturer to verify the correctness of the information on the certificate(s) and, if necessary, to enter in Eudamed the relevant information on the device(s) covered.

Where the notified body and the manufacturer agree on a rolling review of the technical documentation, they shall also agree on a plan for submitting parts of the technical documentation and possible additional interruptions to those referred to in points (b) and (c) of the first subparagraph.The notified body may use two additional interruptions to those referred to in point (b) of the first subparagraph for each additional site covered by the manufacturer’s quality management system to be audited on-site.The notified body shall agree with the manufacturer on the duration of the interruption and inform the manufacturer in writing.

2.The timeline of the conformity assessment activity is interrupted on the day the notified body informs the manufacturer of its requests and resumes, unless otherwise agreed, on the day after the notified body receives the requested information from the manufacturer.

3.In addition to the interruptions referred to in paragraph 1, the notified body shall interrupt the timeline of the conformity assessment activity where an opinion of the EMA, a regulatory authority, an expert panel or an EU reference laboratory is needed.Such interruption shall not be counted and cumulated with those referred to in paragraph 1.The notified body shall inform the manufacturer in writing about the reason for the interruption referred to in the first subparagraph and its expected duration.

4.The duration of any of the interruptions referred to in paragraph 1 shall be extended only if duly justified and the notified body and the manufacturer agree on the extension in writing.