Almost alwaysPartly in force
Artificial Intelligence Act
Regulation (EU) 2024/1689
The EU's core AI law: prohibited practices, AI literacy, transparency, and requirements for high-risk systems and general-purpose models.
- 02.02.2025
- Prohibited practices and AI literacy
- 02.08.2025
- Obligations for general-purpose AI models
- 02.08.2026
- Transparency: disclosing chatbots, labelling generated content
- 02.12.2026
- Machine-readable marking for generative systems placed on the market before 2 Aug 2026 · upcoming
- 02.12.2027
- High-risk systems under Annex III · upcoming
- 02.08.2028
- High-risk systems under Annex I (in regulated products) · upcoming
Almost alwaysIn force
Digital Omnibus on AI
Regulation (EU) 2026/1744
Amends the AI Act: postpones the high-risk deadlines, clarifies the AI literacy duty and adds a new prohibition.
- 27.07.2026
- In force
Almost alwaysIn force
General Data Protection Regulation (GDPR)
Regulation (EU) 2016/679
Lawful basis, data minimisation, security and the rights of people whose data the system processes. Affects almost every business AI system.
- 25.05.2018
- Applies
Depends on the caseIn force
Transfers of personal data outside the EU
GDPR, Chapter V
The EU–US Data Privacy Framework and standard contractual clauses: the legal basis for sending data to cloud models outside the EEA.
When: When the model or cloud processes data outside the EEA (for example in the US).
- 27.06.2021
- Standard contractual clauses (2021/914)
- 10.07.2023
- EU–US Data Privacy Framework (2023/1795)
Depends on the caseIn force
ePrivacy Directive
Directive 2002/58/EC
Cookies and access to information on the user's device. Implemented in Bulgaria through the Electronic Communications Act.
When: When the AI runs on a website or app: chat widgets, cookies, tracking.
- 31.10.2003
- Transposition deadline
Depends on the caseIn force
NIS2 Directive
Directive (EU) 2022/2555
Cyber-risk management, supply-chain security and incident reporting. In Bulgaria, through the Cybersecurity Act.
When: When the client is an essential or important entity under NIS2, or supplies one.
- 18.10.2024
- Applies in the EU
Depends on the caseIn force
Data Act
Regulation (EU) 2023/2854
Access to and sharing of data from connected products, fair contract terms and switching between cloud providers.
When: When the system uses data from connected devices or cloud data-processing services.
- 12.09.2025
- Applies
- 12.09.2026
- Design requirements for new connected products
Depends on the casePartly in force
Cyber Resilience Act
Regulation (EU) 2024/2847
Mandatory cybersecurity requirements for products with digital elements, including software, across their whole life cycle.
When: When the AI solution is placed on the market as a product (software or device).
- 11.09.2026
- Reporting of actively exploited vulnerabilities and incidents
- 11.12.2027
- All requirements · upcoming
Depends on the caseUpcoming
Product Liability Directive
Directive (EU) 2024/2853
Explicitly covers software and AI systems. Until Bulgaria transposes it, Section IV (Art. 130 ff.) of the Consumer Protection Act applies.
When: When the system is offered as a product and could cause damage.
- 09.12.2026
- Transposition deadline; for products placed on the market after this date · upcoming
Depends on the caseIn force
Copyright in the Digital Single Market Directive
Directive (EU) 2019/790
The text-and-data-mining exception (Art. 4) and rightholders' right to opt out. In Bulgaria, through the Copyright Act.
When: When the system is trained or fine-tuned on third-party content.
- 07.06.2021
- Transposition deadline
Depends on the caseIn force
Digital Services Act (DSA)
Regulation (EU) 2022/2065
Content moderation, transparency of recommender systems and protection of users online.
When: When the system is part of an online platform or hosting service.
- 17.02.2024
- Fully applicable
Depends on the caseIn force
European Accessibility Act
Directive (EU) 2019/882
Accessibility requirements for products and services for people with disabilities, including chatbots and customer interfaces.
When: When the AI serves consumers in e-commerce, banking, transport, e-books and similar services.
- 28.06.2025
- Applies
Depends on the caseIn force
General Product Safety Regulation
Regulation (EU) 2023/988
Safety of consumer products, including risks from software updates and connectivity.
When: When the AI is part of a consumer product.
- 13.12.2024
- Applies
Depends on the caseUpcoming
Platform Work Directive
Directive (EU) 2024/2831
Rules on algorithmic management of people: transparency, human oversight and the right to review automated decisions.
When: When the system assigns, evaluates or manages people's work through a digital platform.
- 02.12.2026
- Transposition deadline · upcoming
Depends on the caseIn force
DORA — Digital Operational Resilience Act
Regulation (EU) 2022/2554
ICT risk management and oversight of third-party ICT providers in the financial sector.
When: When the client is a bank, insurer, investment firm or other financial entity.
- 17.01.2025
- Applies
Depends on the caseIn force
Medical devices (MDR and IVDR)
Regulations (EU) 2017/745 and 2017/746
Software, including AI, with a medical purpose is a medical device and must pass a conformity assessment.
When: When the system has a medical or diagnostic purpose.
- 26.05.2021
- MDR applies
- 26.05.2022
- IVDR applies (with transitional periods)
Depends on the caseUpcoming
Machinery Regulation
Regulation (EU) 2023/1230
Safety requirements for machinery, including machines with self-learning safety functions.
When: When the AI controls or protects a machine or industrial equipment.
- 20.01.2027
- Applies · upcoming