Changes from plenary report to adopted text

Removed– the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements set out in Section 2 of Annex I that apply to the manufacturer will be met;

Removed– the design and development control, as well as design and development verification techniques, processes and systematic actions that will be used when designing and developing the products pertaining to the product category covered;

Removed– the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used;

Removed– the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out;

Removed– the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc;

Removed– the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

Removed3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

RemovedIt shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.

RemovedIn addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises, where such premises exist. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

RemovedThe manufacturer or his authorised representative shall be notified of the decision.

RemovedThe notification shall contain the conclusions of the audit and the reasoned assessment decision.

Removed3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

Removed3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

RemovedThe notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

RemovedIt shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Removed4. Surveillance under the responsibility of the notified body

Removed4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

Removed4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, development, production, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

Removed– the quality system documentation;

Removed– the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

Removed– the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

Removed4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

Removed5. Conformity marking and declaration of conformity

Removed5.1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product that satisfies the requirements set out in Section 1 of Annex I to this Regulation.

Removed5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market or for the support period. The declaration of conformity shall identify the product model for which it has been drawn up.

RemovedA copy of the declaration of conformity shall be made available to the relevant authorities upon request.

Removed6. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market or for the support period or the period during which vulnerabilities are handled, keep at the disposal of the national authorities:

Removed– the technical documentation referred to in point 3.1;

Removed– the documentation concerning the quality system referred to in point 3.1;

Removed– the change referred to in point 3.5, as approved;

Removed– the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

Removed7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

RemovedEach notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

Removed8. Authorised representative

RemovedThe manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

RemovedCAPACITY NEEDS OF THE EUROPEAN UNION AGENCY FOR CYBERSECURITY (ENISA)

RemovedIn order to fulfil its obligations under this Regulation and in order not to compromise existing obligations of the Agency under other Union law, the adequate staffing and financing of ENISA shall be ensured. Therefore additional tasks for ENISA under this Regulation shall be accompanied by additional human and financial resources. Nine additional full-time equivalent and corresponding additional appropriations will be needed to cover the additional tasks under this Regulation.