The EU AI Act writes its safety commitments as essential requirements. Harmonised standards turn them into things a person can check. That conversion is where the substance is decided — and it happens in rooms most people never see into.
The Observatory reads the drafts of the M/613 standards against the Regulation itself, in the open, while the enquiry windows are still open to comment.
What this is
Compliance with the AI Act's requirements for high-risk systems runs, in practice, through a small set of technical standards drafted by CEN and CENELEC's Joint Technical Committee 21. Follow one, once its reference is cited in the Official Journal, and you are presumed to conform. The standards are therefore load-bearing law in the shape of voluntary technical documents — and they are being written now.
The Observatory tracks that drafting as it happens. Each brief takes a single requirement, or a single mechanism, and follows it from the words of the Regulation into the clause of the standard that is meant to make it checkable, showing what narrows, what gets reassigned, and who ends up holding the threshold. The work is free to read and exists as public evidence of competence, not as a sales channel.
The Observatory is independent. Its analysis is its own and does not represent the position of CEN, CENELEC, any national standards body, or the European Commission. The standards it discusses are drafts at working, enquiry or final-approval stage; clause numbers and definitions change between revisions and are treated as provisional.
The publication
Twenty-one briefs on the drafting of the M/613 harmonised standards and the law they run on. The first five, marked as the launch set, are the most immediately useful to anyone preparing for inspection from December 2027; the rest build the structural argument beneath them.
Alongside the briefs
An externally accredited course on Article 17 and the quality management system for the AI Act, anchored on the draft standard prEN 18286 and widening to the wider JTC 21 work programme. Built for providers, authorised representatives and conformity teams who need the QMS in place before the high-risk obligations apply.
Delivered in English and Italian, in person or online. The first quality management system cohort is planned for late 2026. If you would like to be told when enrolment opens, follow the Observatory or write to us below.
Follow the work
The briefs publish in waves. Subscribe to read them as they appear, connect on LinkedIn for shorter notes, or write to us directly about training and consultancy.