Article 2 · Commission Implementing Regulation (EU) 2026/977

Contents

Article 2Timelines#

1.For the purposes of Section 4.5.1, second paragraph, third indent, of Annex VII to Regulation (EU) 2017/745 and Section 4.5.1, second paragraph, third indent, of Annex VII to Regulation (EU) 2017/746, the notified body shall have documented procedures to ensure that the shortest possible timeline is agreed with the manufacturer, taking into consideration the following:

(a)the range and type(s) of the devices;

(b)the specific characteristics of the devices and technologies used;

(c)the devices’ risk class(es);

(d)the conformity assessment activities the notified body is to perform.

2.The notified body shall ensure that conformity assessment activities are completed according to the following maximum timelines:

(a)30 days for the application review and the signature of the contract, starting on the day on which the notified body receives the complete application and ending on the day the contract with the manufacturer is signed in accordance with Section 4.3, second paragraph, of Annex VII to Regulation (EU) 2017/745 or with Section 4.3, second paragraph, of Annex VII to Regulation (EU) 2017/746, as applicable;

(b)120 days for the quality management system auditing in accordance with Section 4.5.2 of Annex VII to Regulation (EU) 2017/745 or Section 4.5.2 of Annex VII to Regulation (EU) 2017/746, as applicable, starting on the date the notified body initiates the audit programme’s first activity and ending on the day in which 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, is completed;

(c)90 days for the product verification in accordance with Section 4.5.3 of Annex VII to Regulation (EU) 2017/745 or Section 4.5.3 of Annex VII to Regulation (EU) 2017/746, starting on the day the notified body initiates the assessment of the technical documentation of each device or each representative device and ending on the day in which 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, is completed;

(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.

The conformity assessment activities referred to in points (b) and (c) of the first subparagraph of this paragraph shall be conducted in parallel when carried out in accordance with Annex IX to Regulation (EU) 2017/745 or Annex IX to Regulation (EU) 2017/746, as applicable, provided that the required input from the assessment of the relevant technical documentation is taken into account when developing the audit programme.Unless otherwise agreed between the notified body and the manufacturer, the activities referred to in points (b) and (c) of the first subparagraph of this paragraph shall start the day after the signature of the contract referred to in point (a) of the first subparagraph of this paragraph.

3.The notified body shall complete the assessment of a planned substantial change to the quality management system or to the device range covered by an EU quality management system certificate or an EU quality assurance certificate, and the assessment of a change to the approved device covered by an EU technical documentation assessment certificate or an EU type-examination certificate, in the following maximum timelines:

(a)30 days for reviewing the proposed planned change, starting on the day the notified body receives from the manufacturer information on the planned change with completed documentation, and ending on the day in which the notified body notifies the manufacturer of the decision on whether any additional conformity assessment activities are needed or of the approval of the planned change;

(b)90 days for the additional conformity assessment activities of the planned change, starting on the day the notified body initiates, where necessary, the audit programme’s first activity or on the day the notified body initiates the assessment of the technical documentation, whichever is the earlier, and ending the day the notified body notifies the manufacturer of the approval of the planned change;

(c)20 days for issuing the supplement to the concerned certificate(s), where necessary, starting on the day following that of the notification of the approval of the planned change as referred to in point (a) or (b), and ending on the date the supplement to the concerned certificate(s) is issued and entered in 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.

Where a new conformity assessment procedure is necessary, the timelines referred to in paragraph 2 shall apply.

4.The notified body shall continue the conformity assessment activities until a decision on issuing or refusing a certificate is made. Expiry of the maximum timelines referred to in paragraphs 2 and 3 or the use of the maximum number of interruptions referred to in Article 3 shall not be sufficient reason for the notified body to refuse issuing a certificate or refuse approving a change.