Changes from plenary report to adopted text

Removed1. Internal control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on its sole responsibility that the products with digital elements satisfy all the essential requirements set out in Section 1 of Annex I and the manufacturer meets the essential requirements set out in Section 2 of Annex I.

Removed2. The manufacturer shall draw up the technical documentation described in Annex V.

Removed3. Design, development, production and vulnerability handling of products with digital elements

RemovedThe manufacturer shall take all measures necessary so that the design, development, production and vulnerability handling processes and their monitoring ensure compliance of the manufactured or developed products with digital elements and of the processes put in place by the manufacturer with the essential requirements set out in sections 1 and 2 of Annex I.

Removed4. Conformity marking and declaration of conformity

Removed4.1. The manufacturer shall affix the CE to each individual product with digital elements that satisfies the applicable requirements of this Regulation.

Removed4.2. The manufacturer shall draw up a written EU declaration of conformity for each product with digital elements in accordance with Article 20 and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product with digital elements has been placed on the market or the support period, whichever is longer. The EU declaration of conformity shall identify the product with digital elements for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

Removed5. Authorised representatives

RemovedThe manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

RemovedEU-type examination (based on Module B)

Removed1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design and development of a product and the vulnerability handling processes put in place by the manufacturer, and attests that a product with digital elements meets the essential requirements set out in Section 1 of Annex I and that the manufacturer meets the essential requirements set out in Section 2 of Annex I.

Removed2. EU-type examination shall be carried out by assessment of the adequacy of the technical design and development of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens of one or more critical parts of the product (combination of production type and design type).

Removed3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

RemovedThe application shall include:

Removed– the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

Removed– a written declaration that the same application has not been lodged with any other notified body;

Removed– the technical documentation, which shall make it possible to assess the product's conformity with the applicable essential requirements as set out in Section 1 of Annex I and the manufacturer's vulnerability handling processes set out in Section 2 of Annex I, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain, wherever applicable, at least the elements set out in Annex V;

Removed– the supporting evidence for the adequacy of the technical design and development solutions and vulnerability handling processes. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

Removed4. The notified body shall:

Removed4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design and development of the product with the essential requirements set out in Section 1 of Annex I and of the vulnerability handling processes put in place by the manufacturer with the essential requirements set out in Section 2 of Annex I;

Removed4.2. verify that the specimen(s) have been developed or manufactured in conformity with the technical documentation, and identify the elements which have been designed and developed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed and developed without applying the relevant provisions of those standards;

Removed4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications for the requirements set out in Annex I, these have been applied correctly;

Removed4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications for the requirements set out in Annex I have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements;

Removed4.5. agree with the manufacturer on a location where the examinations and tests will be carried out.

Removed5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

Removed6. Where the type and the vulnerability handling processes meet the essential requirements set out in Annex I, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type and vulnerability handling processes. The certificate may have one or more annexes attached.

RemovedThe certificate and its annexes shall contain all relevant information to allow the conformity of manufactured or developed products with the examined type and vulnerability handling processes to be evaluated and to allow for in-service control.

RemovedWhere the type and the vulnerability handling processes do not satisfy the applicable essential requirements set out in Annex I, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

Removed7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type and the vulnerability handling processes may no longer comply with the applicable essential requirements set out in Annex I to this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

RemovedThe manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type and the vulnerability handling processes that may affect the conformity with the essential requirements set out in Annex I, or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

Removed8. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

RemovedEach notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

RemovedThe Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

Removed9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market or for the support period.

Removed10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

RemovedConformity to type based on internal production control (based on Module C)

Removed1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the essential requirements set out in Section 1 of Annex I.

Removed2. Production

Removed2.1. The manufacturer shall take all measures necessary so that the production and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the essential requirements as set out in Section 1 of Annex I.

Removed3. Conformity marking and declaration of conformity

Removed3.1. The manufacturer shall affix the CE marking to each individual product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of the legislative instrument.

Removed3.2. The manufacturer shall draw up a written declaration of conformity for a 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. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

Removed4. Authorised representative

RemovedThe manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

RemovedConformity based on full quality assurance (based on Module H)

Removed1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products (or product categories) concerned satisfy the essential requirements set out in Section 1 of Annex I, and that the vulnerability handling processes put in place by the manufacturer meet the requirements set out in Section 2 of Annex I.

Removed2. Design, development, production and vulnerability handling of products with digital elements

RemovedThe manufacturer shall operate an approved quality system as specified in point 3 for the design, development, and production of the products concerned and for handling vulnerabilities, maintain its effectiveness throughout the lifecycle of the products concerned, and shall be subject to surveillance as specified in point 4.

Removed3. Quality system

Removed3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

RemovedThe application shall include:

Removed– the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

Removed– the technical documentation for one model of each category of products intended to be manufactured or developed. The technical documentation shall, wherever applicable, contain at least the elements as set out in Annex V;

Removed– the documentation concerning the quality system; and

Removed– a written declaration that the same application has not been lodged with any other notified body.

Removed3.2. The quality system shall ensure compliance of the products with the essential requirements set out in Section 1 of Annex I and compliance of the vulnerability handling processes put in place by the manufacturer with the requirements set out in Section 2 of Annex I.

RemovedAll the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

RemovedIt shall, in particular, contain an adequate description of:

Removed– the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality and vulnerability handling;

Removed– the technical design and development 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 1 of Annex I that apply to the products will be met;