Article 43: Conformity Assessment
Article 43 sets out which conformity assessment procedure a provider must follow before placing a high-risk system on the market: an internal control procedure under Annex VI for most Annex III use cases, or assessment involving a notified body under Annex VII for certain categories such as biometric identification, or where no harmonised standard exists and specific conditions apply.
- 02 Dec 2027 Applies to Annex III high-risk systems
- 02 Aug 2028 Applies to Annex I embedded high-risk systems
- Determine the applicable conformity assessment route for the system's Annex III category or Annex I product route.
- Where the internal control procedure (Annex VI) applies, complete and document the self-assessment before market placement.
- Where notified-body involvement (Annex VII) is required, engage a notified body and obtain its assessment before market placement.
- Re-assess conformity following any substantial modification to the system.
- Keep the conformity assessment report as part of the technical documentation.
- Conformity assessment report
- Notified body certificate, where applicable
Third-party notified-body assessment is often assumed to be the default for all high-risk systems; for most Annex III categories, internal self-assessment under Annex VI is actually the standard route, with notified-body involvement reserved for specific categories or the absence of applicable standards.
What regulators published on Art. 43
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- Regulation (EU) 2024/1689 on EUR-Lex
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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.