CRACRAVigente

Cyber Resilience Act

El CRA impone requisitos obligatorios de ciberseguridad a fabricantes de productos con elementos digitales (hardware y software). Incluye obligaciones de diseño seguro, gestión de vulnerabilidades durante todo el ciclo de vida y notificación de incidentes activamente explotados.

En vigor

11 oct 2027

Articulos

71

Guias oficiales

4

General

71
Art. 1

Subject matter

El artículo 1 (Subject matter) establece obligaciones y criterios operativos dentro del marco DORA. This Regulation lays down: (a) rules for the making available on the market of products with digital elements to ensure the cybersecurity of such products; (b) essential cybersecurity requirements for the design, development and production of products with dig

Art. 2

Scope

El artículo 2 (Scope) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 3

Definitions

El artículo 3 (Definitions) establece obligaciones y criterios operativos dentro del marco DORA. For the purposes of this Regulation, the following definitions apply: (1) ‘product with digital elements’ means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separa

Art. 4

Free movement

El artículo 4 (Free movement) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 5

Procurement or use of products with digital elements

El artículo 5 (Procurement or use of products with digital elements) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 6

Requirements for products with digital elements

El artículo 6 (Requirements for products with digital elements) establece obligaciones y criterios operativos dentro del marco DORA. Products with digital elements shall be made available on the market only where: (a) they meet the essential cybersecurity requirements set out in Part I of Annex I, provided that they are properly installed, maintained, used for their intended purpose or unde

Art. 7

Important products with digital elements

El artículo 7 (Important products with digital elements) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 8

Critical products with digital elements

El artículo 8 (Critical products with digital elements) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 9

Stakeholder consultation

El artículo 9 (Stakeholder consultation) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 10

Enhancing skills in a cyber resilient digital environment

El artículo 10 (Enhancing skills in a cyber resilient digital environment) establece obligaciones y criterios operativos dentro del marco DORA. For the purposes of this Regulation and in order to respond to the needs of professionals in support of the implementation of this Regulation, Member States with, where appropriate, the support of the Commission, the European Cybersecurity Competence Centre an

Art. 11

General product safety

El artículo 11 (General product safety) establece obligaciones y criterios operativos dentro del marco DORA. By way of derogation from Article 2(1), third subparagraph, point (b), of Regulation (EU) 2023/988, Chapter III, Section 1, Chapters V and VII, and Chapters IX to XI of that Regulation shall apply to products with digital elements with respect to aspects and r

Art. 12

High-risk AI systems

El artículo 12 (High-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 13

Obligations of manufacturers

El artículo 13 (Obligations of manufacturers) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 14

Reporting obligations of manufacturers

El artículo 14 (Reporting obligations of manufacturers) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 15

Voluntary reporting

El artículo 15 (Voluntary reporting) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 16

Establishment of a single reporting platform

El artículo 16 (Establishment of a single reporting platform) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 17

Other provisions related to reporting

El artículo 17 (Other provisions related to reporting) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 18

Authorised representatives

El artículo 18 (Authorised representatives) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 19

Obligations of importers

El artículo 19 (Obligations of importers) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 20

Obligations of distributors

El artículo 20 (Obligations of distributors) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 21

Cases in which obligations of manufacturers apply to importers and distributors

El artículo 21 (Cases in which obligations of manufacturers apply to importers and distributors) establece obligaciones y criterios operativos dentro del marco DORA. An importer or distributor shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to Articles 13 and 14, where that importer or distributor places a product with digital elements on the market under its name or tradem

Art. 22

Other cases in which obligations of manufacturers apply

El artículo 22 (Other cases in which obligations of manufacturers apply) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 23

Identification of economic operators

El artículo 23 (Identification of economic operators) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 24

Obligations of open-source software stewards

El artículo 24 (Obligations of open-source software stewards) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 25

Security attestation of free and open-source software

El artículo 25 (Security attestation of free and open-source software) establece obligaciones y criterios operativos dentro del marco DORA. In order to facilitate the due diligence obligation set out in Article 13(5), in particular as regards manufacturers that integrate free and open-source software components in their products with digital elements, the Commission is empowered to adopt delegated

Art. 26

Guidance

El artículo 26 (Guidance) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 27

Presumption of conformity

El artículo 27 (Presumption of conformity) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 28

EU declaration of conformity

El artículo 28 (EU declaration of conformity) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 29

General principles of the CE marking

El artículo 29 (General principles of the CE marking) establece obligaciones y criterios operativos dentro del marco DORA. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Art. 30

Rules and conditions for affixing the CE marking

El artículo 30 (Rules and conditions for affixing the CE marking) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 31

Technical documentation

El artículo 31 (Technical documentation) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 32

Conformity assessment procedures for products with digital elements

El artículo 32 (Conformity assessment procedures for products with digital elements) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 33

Support measures for microenterprises and small and medium-sized enterprises, including start-ups

El artículo 33 (Support measures for microenterprises and small and medium-sized enterprises, including start-ups) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 34

Mutual recognition agreements

El artículo 34 (Mutual recognition agreements) establece obligaciones y criterios operativos dentro del marco DORA. Taking into account the level of technical development and the approach on conformity assessment of a third country, the Union may conclude Mutual Recognition Agreements with third countries, in accordance with Article 218 TFEU, in order to promote and facilit

Art. 35

Notification

El artículo 35 (Notification) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 36

Notifying authorities

El artículo 36 (Notifying authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 37

Requirements relating to notifying authorities

El artículo 37 (Requirements relating to notifying authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 38

Information obligation on notifying authorities

El artículo 38 (Information obligation on notifying authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 39

Requirements relating to notified bodies

El artículo 39 (Requirements relating to notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 40

Presumption of conformity of notified bodies

El artículo 40 (Presumption of conformity of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. Where 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 c

Art. 41

Subsidiaries of and subcontracting by notified bodies

El artículo 41 (Subsidiaries of and subcontracting by notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 42

Application for notification

El artículo 42 (Application for notification) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 43

Notification procedure

El artículo 43 (Notification procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 44

Identification numbers and lists of notified bodies

El artículo 44 (Identification numbers and lists of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 45

Changes to notifications

El artículo 45 (Changes to notifications) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 46

Challenge of the competence of notified bodies

El artículo 46 (Challenge of the competence of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 47

Operational obligations of notified bodies

El artículo 47 (Operational obligations of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 48

Appeal against decisions of notified bodies

El artículo 48 (Appeal against decisions of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.

Art. 49

Information obligation on notified bodies

El artículo 49 (Information obligation on notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 50

Exchange of experience

El artículo 50 (Exchange of experience) establece obligaciones y criterios operativos dentro del marco DORA. The Commission shall provide for the organisation of the exchange of experience between the Member States’ national authorities responsible for notification policy.

Art. 51

Coordination of notified bodies

El artículo 51 (Coordination of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 52

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

El artículo 52 (Market surveillance and control of products with digital elements in the Union market) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 53

Access to data and documentation

El artículo 53 (Access to data and documentation) establece obligaciones y criterios operativos dentro del marco DORA. Where necessary to assess the conformity of products with digital elements and the processes put in place by their manufacturers with the essential cybersecurity requirements set out in Annex I, the market surveillance authorities shall, upon a reasoned reques

Art. 54

Procedure at national level concerning products with digital elements presenting a significant cybersecurity risk

El artículo 54 (Procedure at national level concerning products with digital elements presenting a significant cybersecurity risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 55

Union safeguard procedure

El artículo 55 (Union safeguard procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 56

Procedure at Union level concerning products with digital elements presenting a significant cybersecurity risk

El artículo 56 (Procedure at Union level concerning products with digital elements presenting a significant cybersecurity risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 57

Compliant products with digital elements which present a significant cybersecurity risk

El artículo 57 (Compliant products with digital elements which present a significant cybersecurity risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 58

Formal non-compliance

El artículo 58 (Formal non-compliance) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 59

Joint activities of market surveillance authorities

El artículo 59 (Joint activities of market surveillance authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 60

Sweeps

El artículo 60 (Sweeps) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 61

Exercise of the delegation

El artículo 61 (Exercise of the delegation) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 62

Committee procedure

El artículo 62 (Committee procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 63

Confidentiality

El artículo 63 (Confidentiality) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 64

Penalties

El artículo 64 (Penalties) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 65

Representative actions

El artículo 65 (Representative actions) establece obligaciones y criterios operativos dentro del marco DORA. Directive (EU) 2020/1828 shall apply to the representative actions brought against infringements by economic operators of provisions of this Regulation that harm, or may harm, the collective interests of consumers.

Art. 66

Amendment to Regulation (EU) 2019/1020

El artículo 66 (Amendment to Regulation (EU) 2019/1020) establece obligaciones y criterios operativos dentro del marco DORA. In Annex I to Regulation (EU) 2019/1020, the following point is added: ‘72.

Art. 67

Amendment to Directive (EU) 2020/1828

El artículo 67 (Amendment to Directive (EU) 2020/1828) establece obligaciones y criterios operativos dentro del marco DORA. In Annex I to Directive (EU) 2020/1828, the following point is added: ‘69.

Art. 68

Amendment to Regulation (EU) No 168/2013

El artículo 68 (Amendment to Regulation (EU) No 168/2013) establece obligaciones y criterios operativos dentro del marco DORA. In Part C1, in the table, of Annex II to Regulation (EU) No 168/2013 of the European Parliament and of the Council ( 38 ) , the following entry is added: ‘ 16 18 protection of vehicle against cyberattacks x x x x x x x x x x x x x x ’.

Art. 69

Transitional provisions

El artículo 69 (Transitional provisions) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 70

Evaluation and review

El artículo 70 (Evaluation and review) establece obligaciones y criterios operativos dentro del marco DORA. 1.

Art. 71

Entry into force and application

El artículo 71 (Entry into force and application) establece obligaciones y criterios operativos dentro del marco DORA. 1.