Article 1 · Commission Implementing Regulation (EU) 2026/977

Contents

Article 1Quotations#

1.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:

(a)the manufacturer’s identification, namely its name and address;

(b)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;

(c)name and address of the manufacturer’s authorised representative, where applicable;

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

(e)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;

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

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

(h)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;

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

(j)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.

2.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.

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

(a)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;

(b)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;

(c)the estimated timeline(s).

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