When do common specifications apply under Article 41?

What is a common specification?

A common specification is a document adopted by the Commission by implementing act, setting out technical specifications that a provider can follow to meet the Section 2 requirements. It is a Union-level instrument, distinct from a harmonised standard drawn up by a standardisation organisation, and it is used where the standardisation route has not produced a sufficient solution in time or at all. A common specification should be read as a technical document with a defined scope, version, and date of adoption, and providers should check its current status before relying on it. The specification does not replace the legal requirements; it provides a route to demonstrating them, and the provider must still carry out conformity assessment and keep the documentation that shows the specification was applied correctly for its system.

When can the Commission adopt common specifications?

Article 41 sets conditions for adoption, including, in outline, where no harmonised standard exists, where the Commission considers an existing standard insufficient, or where there is a need to address a specific concern, and after consulting relevant stakeholders and following the procedure the article sets out. The Commission must also consider whether the specification is needed to ensure the proper application of the Act and whether it respects the principles of the standardisation system. Providers should not assume that a common specification will be adopted for a particular requirement, or that a draft specification has legal effect before adoption. The adoption status, the implementing act, and the date should be recorded for any specification relied on, in the same way as a harmonised standard citation.

For the broader regulatory framework, see Conformity assessment and CE marking overview.

How does the presumption work for common specifications?

Conformity with a common specification, or part of one, gives a presumption of conformity with the corresponding Section 2 requirements, to the extent covered by the specification, in the same structured way as a harmonised standard. The provider should map each requirement to the specification clause relied on, record the version and adoption act, and identify any requirement not covered. Partial application gives a presumption only for the part applied. Where a common specification is later amended or repealed, the provider should assess whether the conformity conclusion for systems already on the market is affected, and should record that assessment. A specification that has been repealed or replaced should not continue to be cited as the basis for a new assessment without a fresh check.

How do common specifications affect the Article 43 route?

The availability and application of common specifications affect whether the Annex VII notified-body route is mandatory for Annex III point 1 systems. Where a common specification exists but has not been applied, Article 43 requires the Annex VII route, in the same way as for an unapplied harmonised standard. Where a common specification has been applied in full alongside or instead of a standard, the provider may have the choice between Annex VI and Annex VII for point 1 systems, as Article 43 provides. The provider should therefore check both the standards position and the common specifications position before choosing a route, and should record both checks. A route decision that considers only standards, and ignores an available common specification, may be wrong for a point 1 system.

How should a provider plan for common specifications?

A provider should include common specifications in the same watching brief as harmonised standards, with a named owner, a review cadence, and a trigger for reassessment on adoption, amendment or repeal. The owner should track Commission consultations and implementing acts, inform product teams when a specification becomes available for a requirement they are demonstrating directly, and assess whether adopting the specification would strengthen the file. The provider should also record a decision not to apply an available specification, with reasons, because that decision can affect the conformity route. The watching brief should be part of the quality management system, so that standards and specifications decisions are controlled and auditable, rather than left to individual teams.

Continue with Harmonised standards and presumption of conformity.

What does this guide not decide?

This guide does not state which common specifications have been adopted, which requirements they cover, or whether a provider's use of a specification gives a presumption for a specific system. It does not assess a specification or a mapping. Those matters require checking the current implementing acts and the specification text on the date of the check, and applying them to the specific system. A provider should confirm the status of any specification it relies on with a competent authority or legal adviser, keep the mapping current, and record every status check with its date.

Frequently asked questions

Continue through this AI Act cluster

• Conformity assessment and CE marking overview
• Harmonised standards and presumption of conformity
• Conformity assessment routes under Article 43
• Codes, standards and sandboxes overview
• Provider responsibilities
• How does internal control under Annex VI work?