01
Scope of application & addressees
- Manufacturers and developers supplying AI systems, software or connected products in the European Union
- Businesses integrating an AI system into a product
- Importers, authorised representatives, fulfilment providers and certain online platforms
02
Core regulatory mandates & key requirements
01Software, AI systems and certain digital manufacturing files may qualify as products.
02Updates, learning capability and related digital services can be relevant to the defect assessment.
03Courts can order evidence disclosure and may apply presumptions in technically complex cases.
03
Enforcement & compliance timeline
The Directive was published in the Official Journal.
The Directive entered into force.
The Member State transposition period reaches its deadline.