- ClassificationCategoryCybersecurityDomainCybersecurityFramework FamilyOther
- Regulatory ContextTypeRegulationLegal InstrumentRegulationSectorCross-SectorIndustryCross-Industry
- Region / PublisherRegionEuropeRegion DetailEuropean UnionPublisherEuropean Parliament and Council of the European Union
- VersioningVersionRegulation (EU) 2024/2847Effective DateDecember 10, 2024 (entry into force); reporting duties from September 11, 2026; full application from December 11, 2027Issue DateOctober 23, 2024 (signed); published November 20, 2024
- AdoptionAdoption ModelRegulatory ComplianceImplementation ComplexityHigh
- Official ReferenceOpen Link in New TabSource
License included / downloadable: Yes
The Regulation is EU law published in the Official Journal and is included with the platform for reference.
Framework text is licensed by its publisher and is included only where stated above.
- The EU Cyber Resilience Act (Regulation (EU) 2024/2847) sets cybersecurity requirements for hardware and software with a data connection.
- It entered into force December 10, 2024; reporting duties apply from September 11, 2026 and the full Regulation from December 11, 2027.
- Manufacturers must handle vulnerabilities for a support period of at least five years and report actively exploited vulnerabilities and severe incidents.
- Manufacturer duties include a cybersecurity risk assessment, conformity assessment, technical documentation, an EU declaration of conformity, and CE marking.
- Medical devices, in vitro diagnostic devices, motor vehicles, and certified aviation products are excluded.
Overview
The EU Cyber Resilience Act (Regulation (EU) 2024/2847) requires manufacturers, importers and distributors of products with digital elements, meaning hardware and software with a data connection, to build them to essential cybersecurity requirements, handle vulnerabilities for a support period of at least five years, and report actively exploited vulnerabilities and severe incidents. The Regulation entered into force on December 10, 2024, its reporting duties apply from September 11, 2026 and the full Regulation applies from December 11, 2027.
The European Parliament and the Council adopted it on October 23, 2024. Market surveillance authorities in each Member State enforce it, and ENISA and the national CSIRTs receive vulnerability and incident reports through a single reporting platform (Article 14 and Article 16). Medical devices, in vitro diagnostic devices, motor vehicles and certified aviation products are excluded (Article 2).
Manufacturers carry the main duties (Article 13): a documented cybersecurity risk assessment, conformity assessment, technical documentation kept for at least 10 years or the support period, an EU declaration of conformity, CE marking, and user information that includes a single point of contact for reporting vulnerabilities. Importers and distributors check that the manufacturer has done this before placing products on the market.
Why does it matter?
The CRA moves security into product design. Before, a connected product could be sold with known flaws and no update plan. The Regulation sets a legal baseline for security by design, vulnerability handling and transparency, and makes each economic operator in the supply chain responsible for checking it.
Key benefits include:
- A legal baseline for products
Annex I Part I requires products to be made available without known exploitable vulnerabilities, secure by default, protected against unauthorized access and with security updates (Annex I, Part I (2)).
- Vulnerability handling as a duty
Annex I Part II requires manufacturers to document vulnerabilities and components, including a software bill of materials, test regularly, and run a coordinated vulnerability disclosure policy.
- A support period
Manufacturers set a support period reflecting the expected use time, and it must be at least five years unless the product will be used for less time (Article 13(8)).
- Reporting to authorities
Actively exploited vulnerabilities and severe incidents are reported on a 24-hour, 72-hour and final-report timetable (Article 14).
- Fines scaled to turnover
Breaches of the essential requirements and Articles 13 and 14 can bring fines up to EUR 15 million or 2.5 percent of worldwide turnover (Article 64(2)).
How does it work?
The Regulation applies to products with digital elements made available on the EU market whose intended or reasonably foreseeable use includes a direct or indirect data connection (Article 2(1)). Important products with digital elements in Annex III, split into class I and class II, face stricter conformity assessment (Articles 7 and 32), and critical products in Annex IV may need a European cybersecurity certification scheme.
For most products the manufacturer may use internal control (Annex VIII module A). Class I important products need a third-party route unless harmonized standards are applied, class II products need EU-type examination (module B plus C) or full quality assurance (module H), and critical products follow Article 32(4). The manufacturer then draws up the declaration of conformity (Article 28) and affixes the CE marking (Article 30).
After placing a product on the market the manufacturer keeps handling vulnerabilities throughout the support period, provides security updates free of charge, publicly discloses fixed vulnerabilities and reports under Article 14. Distributors and importers check the CE marking, documentation and manufacturer contact details.
Key Elements
- Essential requirements (Annex I, Part I)
Thirteen requirements covering known exploitable vulnerabilities, secure-by-default configuration, security updates, access control, encryption and integrity, data minimization, availability, attack surface, incident impact, logging and secure data removal.
- Vulnerability handling (Annex I, Part II)
Identify and document vulnerabilities and components with a software bill of materials, fix without delay, test regularly, disclose fixed vulnerabilities, keep a coordinated disclosure policy, and distribute updates securely.
- Manufacturer obligations (Article 13)
Risk assessment in the technical documentation, due diligence on third-party and open-source components, documentation kept at least 10 years or the support period, and a single point of contact.
- Reporting obligations (Article 14)
An early warning within 24 hours, a notification within 72 hours and a final report within 14 days of a fix for actively exploited vulnerabilities, or within one month of the notification for severe incidents.
- Conformity assessment (Article 32 and Annexes III, IV and VIII)
The route depends on whether the product is default, important class I or II, or critical.
- Penalties (Article 64)
Up to EUR 15 million or 2.5 percent for essential requirement and Article 13 and 14 breaches, EUR 10 million or 2 percent for other obligations and EUR 5 million or 1 percent for misleading information.
What does it cover?
The CRA applies to manufacturers, importers and distributors of products with digital elements placed on the EU market, whether made inside or outside the Union. It does not apply to products covered by the medical device, in vitro diagnostic and motor vehicle regulations, to products certified under the EU aviation safety regulation, to spare parts or to products made only for national security or defense (Article 2). Open-source software is covered when it is made available in the course of commercial activity.
What are its objectives?
The CRA sets security requirements for products from design to the end of support.
Make products with digital elements secure by design and by default.
Require vulnerability handling and security updates throughout a support period.
Make manufacturers report actively exploited vulnerabilities and severe incidents.
Give buyers clear security information and a contact point.
Let market surveillance authorities check conformity and fine non-compliance.
Framework in Context
The CRA protects products, while the NIS2 Directive protects the operators that use networks and information systems. Reports under Article 14 go to the CSIRT coordinator and ENISA, and for products that must also meet sector rules the CRA can be limited or excluded where those rules give equal or higher protection (Article 2(5)). Harmonized standards, Commission implementing acts and European cybersecurity certification schemes will supply technical detail.
Common Framework Mappings
Organizations commonly map CRA obligations to complementary European and international standards to harmonize product security, legal compliance, operational resilience, and data protection across development and incident response processes.
Mapped frameworks include:
Common Criteria (ISO/IEC 15408)
Digital Operational Resilience Act (DORA)
ETSI EN 303 645
General Data Protection Regulation (GDPR)
IEC 62443
ISO/IEC 27001
NIS2 Directive
NIST Secure Software Development Framework (SSDF)
How SmartSuite Supports EU CRA
SmartSuite provides the system for managing controls, evidence, mappings, assessments, and reporting.
Use Compliance Management and Cyber & IT Risk to hold the Annex I requirements for each product, the risk assessment, the support period, the conformity evidence and the Article 14 reports, and Third Party Risk Management to track component suppliers.
Product and Class Register
Record each product with digital elements, its Annex III class, the conformity route chosen and the manufacturer, importer or distributor role.
Annex I Requirement Library
Map the Part I and Part II requirements to design controls and test evidence, with justification where a requirement does not apply (Article 13(4)).
Component and SBOM Tracking
Keep the software bill of materials, open-source and third-party component owners and the vulnerabilities reported upstream (Article 13(5) and (6)).
Support Period and Update Plan
Record the support period end date, security update releases and public disclosure of fixed vulnerabilities (Article 13(8) and Annex I, Part II).
Article 14 Reporting Workflow
Time each exploited vulnerability or severe incident against the 24-hour, 72-hour and final-report deadlines, with the report platform record (Article 14).
Technical File and Declaration
Keep technical documentation, the EU declaration of conformity and CE marking evidence for at least 10 years or the support period (Article 13(13)).
Related frameworks

DORA (Regulation (EU) 2022/2554) requires EU financial entities to manage ICT risk, report major incidents, test resilience and control ICT third-party risk, applying from January 17, 2025.

The GDPR (Regulation (EU) 2016/679) sets principles, lawful bases, individual rights and accountability duties for personal data, with fines up to EUR 20 million or 4 percent of turnover.

IEC 62443-4-2:2019 sets technical security requirements for IACS components, with seven foundational requirements and security levels 1 to 4.

ISO/IEC 27001:2022 specifies requirements for an information security management system: Clauses 4 to 10, risk treatment, the Statement of Applicability and 93 Annex A controls.
Frequently Asked Questions For EU Cyber Resilience Act (CRA)
Manufacturers, importers and distributors of products with digital elements made available on the EU market, whether made inside or outside the Union (Article 2). Medical devices, in vitro diagnostic devices, motor vehicles, certified aviation products and spare parts are among the exclusions.
The Regulation entered into force on December 10, 2024. Article 14 reporting obligations apply from September 11, 2026 and the rest of the Regulation from December 11, 2027 (Article 71).
Actively exploited vulnerabilities and severe incidents are reported through the single reporting platform to the CSIRT coordinator and ENISA: an early warning within 24 hours, a notification within 72 hours, and a final report within 14 days after a fix is available for vulnerabilities, or within one month of the notification for incidents (Article 14).
The manufacturer sets the support period to reflect how long the product is expected to be in use. It must be at least five years unless the product is expected to be used for less time, and its end date is stated at the time of purchase (Article 13(8) and (19)).
Up to EUR 15 million or 2.5 percent of worldwide annual turnover for breaches of the essential requirements or Articles 13 and 14, whichever is higher. Other listed obligations carry up to EUR 10 million or 2 percent, and misleading information up to EUR 5 million or 1 percent (Article 64).

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