Changes from plenary report to adopted text

Removed5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Where the product with digital elements is subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the product also fulfils the requirements of that other legislation.

Removed6. After consulting the Expert Group, the dedicated administrative cooperation group (ADCO) and, where necessary, other relevant stakeholders, the Commission may, by means of implementing acts, lay down technical specifications for labelling schemes, including harmonised labels, pictograms or any other marks related to the security of the products with digital elements, their support period and mechanisms to promote their use among businesses and consumers and to increase public awareness about the security of products with digital elements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(2).

Removed1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the product with digital elements and the processes put in place by the manufacturer comply with the essential requirements set out in Annex I. It shall at least contain the elements set out in Annex V.

Removed2. The technical documentation shall be drawn up before the product with digital elements is placed on the market and shall be continuously updated, where appropriate, during at least the support period▌.

Removed3. For products with digital elements referred to in Articles 8 and 24(4) that are also subject to other Union acts, one single technical documentation shall be drawn up containing the information referred to in Annex V of this Regulation and the information required by those respective Union acts.

Removed4. The technical documentation and correspondence relating to any conformity assessment procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.

Removed5. The Commission is empowered to adopt delegated acts in accordance with Article 50 to supplement this Regulation by the elements to be included in the technical documentation set out in Annex V to take account of technological developments, as well as developments encountered in the implementation process of this Regulation. The Commission shall ensure that the administrative burden on microenterprises and small and medium-sized enterprises is proportionate.

Removed1. The manufacturer shall perform a conformity assessment of the product with digital elements and the processes put in place by the manufacturer to determine whether the essential requirements set out in Annex I are met. The manufacturer or the manufacturer’s authorised representative shall demonstrate conformity with the essential requirements by using one of the following procedures:

Removed(a) the internal control procedure (based on module A) set out in Annex VI; or

Removed(b) the EU-type examination procedure (based on module B) set out in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

Removed(c) conformity assessment based on full quality assurance (based on module H) set out in Annex VI;

Removed(ca) a European cybersecurity certification scheme adopted pursuant to Regulation (EU) 2019/881 in accordance with Article 18(4).

Removed2. Where, in assessing the compliance of the critical product with digital elements of class I as set out in Annex III and the processes put in place by its manufacturer with the essential requirements set out in Annex I, the manufacturer or the manufacturer’s authorised representative has not applied or has applied only in part harmonised standards, common specifications or European cybersecurity certification schemes at assurance level ‘substantial’ or “high’ as referred to in Article 18, or where such harmonised standards, common specifications or European cybersecurity certification schemes do not exist, the product with digital elements concerned and the processes put in place by the manufacturer shall be submitted with regard to those essential requirements to either of the following procedures:

Removed(a) EU-type examination procedure (based on module B) provided for in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

Removed(b) conformity assessment based on full quality assurance (based on module H) set out in Annex VI.

Removed2a. Harmonised standards, common specifications or European cybersecurity certification schemes shall be in place for six months before the conformity assessment procedure referred to in paragraph 2 of this Article applies. In the six months prior to the application of paragraph 2 of this Article, or where, harmonised standards, common specifications or European cybersecurity certification schemes do not exist, manufacturers shall demonstrate the conformity of the critical product with digital elements of class I as set out in Annex III by means of the procedure referred to in paragraph 1 of this Article.

Removed3. Where the product is a critical product with digital elements of class II as set out in Annex III, the manufacturer or the manufacturer’s authorised representative shall demonstrate conformity with the essential requirements set out in Annex I by using one of the following procedures:

Removed(-a) a European cybersecurity certificate, under a European cybersecurity certification scheme at assurance level ‘substantial’ or ‘high’ pursuant to Regulation (EU) 2019/881;

Removed(a) EU-type examination procedure (based on module B) set out in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

Removed(b) conformity assessment based on full quality assurance (based on module H) set out in Annex VI.

Removed3a. The Commission shall request ENISA to prepare the missing candidate schemes in accordance with Article 48 of Regulation (EU) 2019/881.

Removed4. Manufacturers of products with digital elements that are classified as EHR systems under ▌Regulation [the European Health Data Space Regulation] shall demonstrate conformity with the essential requirements laid down in Annex I of this Regulation using the relevant conformity assessment procedure as required by Regulation [Chapter III of the European Health Data Space Regulation].

Removed5. Notified bodies shall take into account the specific interests and needs of microenterprises and small and medium-sized enterprises ▌ when setting the fees for conformity assessment procedures and reduce those fees proportionately to their specific interests and needs. The Commission shall ensure appropriate financial support in the regulatory framework of existing Union programmes, in particular in order to ease the financial burden on microenterprises and on small and medium-sized enterprises.

RemovedIn order to promote international trade, the Commission shall endeavour to conclude Mutual Recognition Agreements (MRAs) with third countries. The Union shall establish MRAs only with third countries that are on a comparable level of technical development and have a compatible approach concerning conformity assessment. The MRAs shall ensure the same level of protection as that provided for by this Regulation.

RemovedNOTIFICATION OF CONFORMITY ASSESSMENT BODIES

RemovedMember States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.

Removed1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 31.

Removed2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

Removed1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

Removed2. A notifying authority shall be organised and shall function so as to safeguard the objectivity and impartiality of its activities.

Removed3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

Removed4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on commercial or competitive basis.

Removed5. A notifying authority shall safeguard the confidentiality of the information it obtains.

Removed6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Removed6a. A notifying authority shall minimise administrative burden and fees imposed, in particular, on microenterprises and small and medium-sized enterprises.

Removed1. Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

Removed1a. Member States shall, by ... [24 months after the date of entry into force of this Regulation], ensure that there is a sufficient number of notified bodies in the Union to carry out conformity assessments, in order to avoid bottlenecks and hindrances to market entry.

Removed2. The Commission shall make that information publicly available.

Removed1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 12.

Removed2. A conformity assessment body shall be established under national law and have legal personality.

Removed3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.

RemovedA body belonging to a business association or professional federation representing undertakings involved in the design, development, production, provision, assembly, use or maintenance of products with digital elements which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

Removed4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, developer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products with digital elements which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.

RemovedA conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, development, production, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

RemovedConformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

Removed5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

Removed6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks referred to in Annex VI and in relation to which it has been notified, regardless of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

RemovedAt all times and for each conformity assessment procedure and each kind or category of products with digital elements in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

Removed(a) staff with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

Removed(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

Removed(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

RemovedIt shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

Removed7. The personnel responsible for carrying out conformity assessment activities shall have the following:

Removed(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

Removed(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

Removed(c) appropriate knowledge and understanding of the essential requirements set out in Annex I, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of its implementing acts;

Removed(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

Removed7a. Member States and the Commission shall put in place appropriate measures to ensure sufficient availability of skilled professionals, in order to minimise bottlenecks in the activities of conformity assessment bodies and facilitate the compliance of economic operators with this Regulation.

Removed8. The impartiality of the conformity assessment bodies, their top level management and of the assessment personnel shall be guaranteed.

RemovedThe remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.