Part I Conformity Assessment procedure based on internal control (based on Module A)
1. 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 Annex I, Part I, and the manufacturer meets the essential requirements set out in Annex I, Part II.
2. The manufacturer shall draw up the technical documentation described in Annex VII.
3. Design, development, production and vulnerability handling of products with digital elements
The 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 Annex I, Parts I and II.
4. Conformity marking and declaration of conformity
4.1. The manufacturer shall affix the CE marking to each individual product with digital elements that satisfies the applicable requirements of this Regulation.
4.2. The manufacturer shall draw up a written EU declaration of conformity for each product with digital elements in accordance with Article 28 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 for 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.
5. Authorised representatives
The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Part II EU-type examination (based on Module B)
1. 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 with digital elements 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 Annex I, Part I, and that the manufacturer meets the essential requirements set out in Annex I, Part II.
2. EU-type examination shall be carried out by assessment of the adequacy of the technical design and development of the product with digital elements 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).
3. The manufacturer shall lodge an application for EU-type examination with a single notified body of its choice.
The application shall include:
3.1 the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
3.2 a written declaration that the same application has not been lodged with any other notified body;
3.3 the technical documentation, which shall make it possible to assess the conformity of the product with digital elements with the applicable essential requirements as set out in Annex I, Part I, and the manufacturer’s vulnerability handling processes set out in Annex I, Part II, and shall include an adequate analysis and assessment of the risks. 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 with digital elements. The technical documentation shall contain, wherever applicable, at least the elements set out in Annex VII;
3.4 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 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 its behalf and under its responsibility.
4. The notified body shall:
4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design and development of the product with digital elements with the essential requirements set out in Annex I, Part I, and of the vulnerability handling processes put in place by the manufacturer with the essential requirements set out in Annex I, Part II;
4.2. verify that specimens 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 or technical specifications, as well as the elements which have been designed and developed without applying the relevant provisions of those standards;
4.3. carry out appropriate examinations and tests, or have them carried out, to check that, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or technical specifications for the requirements set out in Annex I, they have been applied correctly;
4.4. carry out appropriate examinations and tests, or have them carried out, to check that, where the solutions in the relevant harmonised standards 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;
4.5. agree with the manufacturer on a location where the examinations and tests will be carried out.
5. 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.
6. 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.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured or developed products with digital elements with the examined type and vulnerability handling processes to be evaluated and to allow for in-service control.
Where 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.
7. 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.
The 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.
8. The notified body shall carry out periodic audits to ensure that the vulnerability handling processes as set out in Annex I, Part II, are implemented adequately.
9. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and 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 any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and any 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.
10. 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 with digital elements has been placed on the market or for the support period, whichever is longer.
11. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 10, provided that they are specified in the mandate.
Part III Conformity to type based on internal production control (based on Module C)
1. 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 with digital elements concerned are in conformity with the type described in the EU-type examination certificate and satisfy the essential requirements set out in Annex I, Part I, and that the manufacturer meets the essential requirements set out in Annex I, Part II.
2. Production
The manufacturer shall take all measures necessary so that the production and its monitoring ensure conformity of the manufactured products with digital elements with the approved type described in the EU-type examination certificate and with the essential requirements as set out in Annex I, Part I, and ensures that the manufacturer meets the essential requirements set out in Annex I, Part II.
3. Conformity marking and declaration of conformity
3.1. The manufacturer shall affix the CE marking to each individual product with digital elements that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of the legislative instrument.
3.2. 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 with digital elements has been placed on the market or for the support period, whichever is longer. 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.
4. Authorised representative
The manufacturer’s obligations set out in point 3 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Part IV Conformity based on full quality assurance (based on Module H)
1. 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 its sole responsibility that the products with digital elements or product categories concerned satisfy the essential requirements set out in Annex I, Part I, and that the vulnerability handling processes put in place by the manufacturer meet the requirements set out in Annex I, Part II.
2. Design, development, production and vulnerability handling of products with digital elements
The manufacturer shall operate an approved quality system as specified in point 3 for the design, development and final product inspection and testing of the products with digital elements concerned and for handling vulnerabilities, maintain its effectiveness throughout the support period, and shall be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the products with digital elements concerned.
The application shall include:
— the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
— the technical documentation for one model of each category of products with digital elements intended to be manufactured or developed. The technical documentation shall, wherever applicable, contain at least the elements as set out in Annex VII;
— the documentation concerning the quality system; and
— a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality system shall ensure compliance of the products with digital elements with the essential requirements set out in Annex I, Part I, and compliance of the vulnerability handling processes put in place by the manufacturer with the requirements set out in Annex I, Part II.
All 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.
It shall, in particular, contain an adequate description of:
— the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality and vulnerability handling;
— the technical design and development specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements set out in Annex I, Part I, that apply to the products with digital elements will be met;
— the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements set out in Annex I, Part II, that apply to the manufacturer will be met;
— 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 with digital elements pertaining to the product category covered;
— the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used;
— the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out;
— the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned;
— the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It 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 or technical specification.
In 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 shall have 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 digital elements with those requirements.
The manufacturer or its authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
3.4. 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.
3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
The 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.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. 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:
— the quality system documentation;
— the quality records as provided for by the design part of the quality system, such as results of analyses, calculations and tests;
— the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.
4.3. 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.
5. Conformity marking and declaration of conformity
5.1. 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 with digital elements that satisfies the requirements set out in Annex I, Part I, to this Regulation.
5.2. 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 with digital elements has been placed on the market or for the support period, whichever is longer. 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.
6. The manufacturer shall, for a period ending at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer, keep at the disposal of the national authorities:
6.1 the technical documentation referred to in point 3.1;
6.2 the documentation concerning the quality system referred to in point 3.1;
6.3 the change referred to in point 3.5, as approved;
6.4 the decisions and reports of the notified body referred to in points 3.5 and 4.3.
7. 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.
Each 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.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
