Why December 2027 is no breather: harmonised standards and presumption of conformity

The postponement of high-risk to December 2027 has been read in many HR-techs as a sixteen-month breather. It is one only if you ignore why the postponement arrived. The cause is not political, it is technical: the harmonised standards that let you demonstrate conformity were not ready, and without them the original date did not hold.

Who writes the standards and why they are late

The Commission tasked CEN and CENELEC, through their joint committee JTC 21, with developing the harmonised standards for the high-risk requirements. The mandate dates from May 2023, amended in June 2025. They did not meet the requested deadline, August 2025, and the complete standards may not be available before December 2026. That delay put the entry into application of high-risk on 2 August 2026 at risk and was one of the reasons for the Digital Omnibus postponement to 2 December 2027.

What presumption of conformity is, and what does not trigger it

Here is the mechanic worth understanding. Whoever develops a high-risk system in conformity with a harmonised standard enjoys a presumption of conformity: it is assumed to meet the requirements that standard covers, which removes much of the burden of proof. But that presumption comes with strict conditions, and a draft does not trigger it:

• The standard must be finalised, not in draft stage.
• It must be harmonised, that is, adopted as the European reference standard for the regulation.
• Its reference must have been published in the Official Journal of the European Union.
• A JTC 21 working draft, however advanced, does not grant presumption of conformity.

Hence the trap of the breather. Building today against a draft does not give you the presumption, because the standard does not yet exist as such. But what you can bring forward does not depend on its publication: the inventory of your systems, the preliminary purpose-based classification, the technical documentation, human oversight and the Article 50 transparency, in force since August 2026, do not wait until December 2027.