Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council

For the purpose of issuing quotations to manufacturers as referred to in Section 4.2, point (d), of Annex VII to Regulation (EU) 2017/745 or in Section 4.2, point (d) of Annex VII to Regulation (EU) 2017/746, as the case may be, the notified body shall have documented procedures that ensure that it only issues quotations where it has received from the manufacturer the following information:

1. the manufacturer’s identification, namely its name and address;

2. the information necessary for the notified body to determine if the manufacturer is a micro, small or medium-sized enterprise as defined in Commission Recommendation 2003/361/EC, namely the number of employees and the annual turnover;

3. name and address of the manufacturer’s authorised representative, where applicable;

4. addresses, number of employees, number of work shifts and descriptions of activities performed for each site covered by the manufacturer’s quality management system;

5. name and address of the manufacturer’s suppliers and sub-contractors where design and manufacture activities that are relevant for the conformity assessment activities are performed, including a description of the activities performed by those entities;

6. description of the device(s), their intended purpose, any specific characteristics or specific technologies or processes used, and the risk-classification;

7. the conformity assessment procedure(s) for which the manufacturer applies;

8. for the changes and modifications referred to in Section 4.9 of Annex VII to Regulation (EU) 2017/745 or Section 4.9 of Annex VII to Regulation (EU) 2017/746, as applicable, a detailed description of the planned changes or modifications;

9. for re-certification, identification of affected certificate(s), including possible scope change(s) described as referred to in point (h);

10. any other information regarding the manufacturer, such as its organisational structure or valid certificates, and regarding the device, which are necessary to estimate the activities to be performed.

For the purpose of issuing quotations for conformity assessment activities related to changes and modifications as referred to in points (h) or re-certification referred to in point (i), the notified body shall refrain from seeking the information referred to in points (b) to (g), provided that the manufacturer confirms there have been no changes to the information submitted.

The notified body shall ensure that, in the documented procedures referred to in paragraph 1, the exchanges of technical information and regulatory guidance, namely the structured dialogue with manufacturers, cover aspects relevant to issue quotations, including the information listed in paragraph 1.

The notified body shall issue a quotation which includes at least the following:

1. the estimated overall costs, which are detailed for the assessment of the quality management system and the technical documentation, as applicable, and include typical costs for surveillance activities and unannounced audits;

2. an estimation of potential extra costs arising during the assessment activities; such estimations may refer to hourly fees only when the duration of the specific activity cannot be predetermined;

3. the estimated timeline(s).

The notified body shall inform the manufacturer in advance about any increase above 10 % of the estimated costs, giving reason of such an increase.

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:

1. the range and type(s) of the devices;

2. the specific characteristics of the devices and technologies used;

3. the devices’ risk class(es);

4. the conformity assessment activities the notified body is to perform.

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

1. 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;

2. 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;

3. 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;

4. 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.

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:

1. 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;

2. 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;

3. 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.

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.

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:

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

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

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

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

5. three times in total for the reviews and verifications referred to in Articles 5 and 6;

6. 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.

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.

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.

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.

The notified body shall establish, document and implement, as part of its quality management system as referred to in Section 2.1 of Annex VII to Regulation (EU) 2017/745 and in Section 2.1 of Annex VII to Regulation (EU) 2017/746, a system to monitor the duration of conformity assessment activities and their costs.

The monitoring system referred to in paragraph 1 shall provide the following information:

1. on the duration of conformity assessment activities:

   1. percentage of conformity assessment activities completed in accordance with the maximum timelines set out in Article 2;

   2. median duration of conformity assessment activities from the date of application to the date of certification, in days;

2. on the costs of conformity assessment activities, the median total cost of completed conformity assessment activities, in euro.

The total costs of conformity assessment activities shall be understood as the sum of all the fees applied by a notified body to a manufacturer for the activities performed during the timeline including any administrative charges.

The monitoring system referred to in paragraph 1 shall provide the information referred to in paragraph 2, points (a) and (b), for the following activities:

1. conformity assessment activities carried out in accordance with Chapters I and II of Annex IX, Annex X and Parts A or B of Annex XI to Regulation (EU) 2017/745, or Chapters I and II of Annex IX, Annex X and Annex XI to Regulation (EU) 2017/746;

2. the assessment of the changes referred to in Article 2(3).

By 30 April of every year, the notified body shall draw up an annual report on timelines and costs of conformity assessment activities that presents the information referred to in paragraphs 2 and 3. It shall consider, in the report, the conformity assessment activities it completed during the previous year. The notified body shall publish the report on its website and inform the authority responsible for the notified body and the Commission.