Article 16: Provider Obligations Bundle
Article 16 is the consolidating provision listing everything a provider of a high-risk system must do: comply with Articles 9 to 15, have a quality management system, keep documentation and logs, carry out conformity assessment, affix CE marking, register the system, take corrective action if needed, and cooperate with authorities. It does not create separate new content beyond referencing these duties.
- 02 Dec 2027 Applies to Annex III high-risk systems
- 02 Aug 2028 Applies to Annex I embedded high-risk systems
- Ensure the system complies with Articles 9 to 15 before market placement.
- Indicate the provider's name, registered trade name or trademark, and contact details on the system, packaging, or documentation.
- Have a quality management system in place per Article 17.
- Keep the documentation referred to in Article 18 and the logs referred to in Article 19.
- Ensure the system undergoes the relevant conformity assessment procedure before market placement.
- Draw up an EU declaration of conformity per Article 47 and affix CE marking per Article 48.
- Register the system in the EU database per Article 49.
- Take corrective action, withdraw, recall, or disable the system where it is found non-conformant, and cooperate with competent authorities.
- Full provider compliance file: risk management, technical documentation, QMS, conformity assessment report, declaration of conformity
Article 16 is sometimes mistaken for an additional standalone obligation on top of Articles 9-15; it is a bundling/reference article that consolidates the provider's full duty list, including duties defined elsewhere such as CE marking and registration.
What regulators published on Art. 16
- Loading from the public feed…
- Regulation (EU) 2024/1689 on EUR-Lex
- Look for Article 16
- Deadline changes and the acts behind them
Get told when Art. 16 moves.
Deadlines under this regulation have already shifted once in 2026. A signed webhook, a REST API and an MCP server carry the same record this page is built from, so your systems learn about the next change without anyone re-reading the text. Free during the beta.
Get free accessInformational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.