Changes from plenary report to adopted text

Removed9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

Removed10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex VI or any provision of national law giving effect to it, except in relation to the market surveillance authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected in accordance with Article 52. The conformity assessment body shall have documented procedures ensuring compliance with this paragraph.

Removed11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 40 and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Removed12. Conformity assessment bodies shall operate in accordance with a set of consistent, fair and reasonable terms and conditions in accordance with Article 37(2), in particular taking into account the interests of microenterprises and small and medium-sized enterprises in relation to fees.

RemovedWhere a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 29 in so far as the applicable harmonised standards cover those requirements.

Removed1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 29 and shall inform the notifying authority accordingly.

Removed2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

Removed3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the manufacturer.

Removed4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.

Removed1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

Removed2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment procedure or procedures and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 29.

Removed3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 29.

Removed1. Notifying authorities may notify only conformity assessment bodies, which have satisfied the requirements laid down in Article 29.

Removed2. The notifying authority shall notify the Commission and the other Member States using the New Approach Notified and Designated Organisations (NANDO) information system developed and managed by the Commission.

Removed3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and product or products concerned and the relevant attestation of competence.

Removed4. Where a notification is not based on an accreditation certificate as referred to in Article 32(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 29.

Removed5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.

RemovedOnly such a body shall be considered a notified body for the purposes of this Regulation.

Removed6. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.

Removed1. The Commission shall assign an identification number to a notified body.

RemovedIt shall assign a single such number even where the body is notified under several Union acts.

Removed2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been allocated to them and the activities for which they have been notified.

RemovedThe Commission shall ensure that that list is kept up to date.

Removed1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 29, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

Removed2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Removed1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

Removed2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.

Removed3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

Removed4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including de-notification if necessary.

Removed1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Article 24 and Annex VI.

Removed2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators, with consideration for microenterprises and small and medium-sized enterprises. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity and the risk exposure of the product type and technology in question and the mass or serial nature of the production process.

Removed3. Notified bodies shall however respect the degree of rigour and the level of protection required for the compliance of the product with the provisions of Regulation.

Removed4. Where a notified body finds that requirements laid down in Annex I or in corresponding harmonised standards or in common specifications as referred to in Article 19 have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate.

Removed5. Where, in the course of the monitoring of conformity following the issuance of a certificate, a notified body finds that a product no longer complies with the requirements laid down in this Regulation, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

Removed6. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.

Removed1. Notified bodies shall inform the notifying authority of the following:

Removed(a) any refusal, restriction, suspension or withdrawal of a certificate;

Removed(b) any circumstances affecting the scope of and conditions for notification;

Removed(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

Removed(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

Removed2. Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

RemovedThe Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

Removed1. The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place, taking also in account the need to reduce the administrative burden and fees, and properly operated in the form of a cross-sectoral group of notified bodies.

Removed2. Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

RemovedMARKET SURVEILLANCE AND ENFORCEMENT

RemovedArticle 41 Market surveillance and control of products with digital elements in the Union market

Removed1. Regulation (EU) 2019/1020 shall apply to the products with digital elements that fall within the scope of this Regulation.

Removed2. Each Member State shall designate one or more market surveillance authorities for the purpose of ensuring the effective implementation of this Regulation. Member States may designate an existing or new authority to act as market surveillance authority for this Regulation.

Removed3. Where relevant, the market surveillance authorities shall cooperate with the national cybersecurity certification authorities designated under Article 58 of Regulation (EU) 2019/881, competent authorities and CSIRTs designated pursuant to Directive (EU) 2022/2555 and exchange information on a regular basis. ▌

Removed3a. With respect to the supervision of the implementation of the reporting obligations pursuant to Article 11 of this Regulation, the designated market surveillance authorities shall cooperate with ENISA. The market surveillance authorities may request ENISA to provide technical advice on matters related to the implementation and enforcement of this Regulation. When conducting an investigation under Article 43, market surveillance authorities may request ENISA to provide non-binding evaluations of compliance of products with digital elements.

Removed4. Where relevant, the market surveillance authorities shall cooperate with other market surveillance authorities designated on the basis of other Union harmonisation legislation for other products, and exchange information on a regular basis.

Removed5. Market surveillance authorities shall cooperate, as appropriate, with the authorities supervising Union data protection law. Such cooperation includes informing these authorities of any finding relevant for the fulfilment of their competences, including when issuing guidance and advice pursuant to paragraph 8 of this Article if such guidance and advice concerns the processing of personal data.

RemovedAuthorities supervising Union data protection law shall have the power to request and access any documentation created or maintained under this Regulation when access to that documentation is necessary for the fulfilment of their tasks. They shall inform the designated market surveillance authorities of the Member State concerned of any such request.

Removed6. Member States shall ensure that the designated market surveillance authorities are provided with adequate financial and human resources, with appropriate cybersecurity skills, in order to fulfil their tasks under this Regulation.

Removed7. The Commission shall facilitate the regular and structured exchange of experience between designated market surveillance authorities.

Removed8. Market surveillance authorities may provide guidance and advice to economic operators on the implementation of this Regulation as well as on non-technical risk factors, with the support of CSIRTs, ENISA and the Commission.

Removed8a. Market surveillance authorities shall be equipped to receive complaints by consumers in accordance with Article 11 of Regulation 2019/1020, including by establishing clear and accessible mechanisms to facilitate reporting of vulnerabilities, incidents and cyber threats.

Removed9. The market surveillance authorities shall report to the Commission on an annual basis the outcomes of relevant market surveillance activities. The designated market surveillance authorities shall report, without delay, to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union competition law.

RemovedMarket surveillance authorities shall provide the Commission with data about the average support period set by the manufacturers, as well as when available the average expected product lifetime, and disaggregated per category of product with digital elements. The Commission shall analyse this information and publish it in a publicly accessible and user-friendly database.

Removed9a. The Commission shall evaluate the reported data including pursuant to paragraph 9 of this Article for the purpose of the reports referred to in Article 56. Where the reported data suggests an increased level of non-compliance in specific categories of products, the Commission, after consulting the Expert Group and ADCO, may recommend that surveillance authorities focus closely on the product categories concerned.