Article 41: Common Specifications
Article 41 is a fallback mechanism. Where harmonised standards under Article 40 do not exist or are insufficient to cover the AI Act's requirements, the Commission may adopt common specifications by means of implementing acts. These are technical specifications that provide an alternative means to comply with the AI Act. Compliance with common specifications also gives a presumption of conformity. The Commission must consult the AI Board and relevant stakeholders before adopting them. Providers may choose not to follow common specifications if they demonstrate that their alternative solutions meet the same level of protection.
Who does this apply to?
- -The European Commission, which adopts common specifications by implementing acts after consulting the AI Board and stakeholders
- -Providers of high-risk AI systems who may comply with common specifications for a presumption of conformity
- -Providers who choose alternative technical solutions and must demonstrate equivalent protection levels
Scenarios
CEN/CENELEC has not yet published a harmonised standard covering the data governance requirements of Article 10. The Commission adopts a common specification for data quality and representativeness by implementing act, after consulting the AI Board.
A provider disagrees with the testing methodology prescribed in a common specification, believing their proprietary testing framework provides equal or better coverage. The provider documents a detailed equivalence analysis.
When and how common specifications are adopted
Common specifications are adopted by the Commission through implementing acts — a legislative procedure that allows the Commission to set technical rules where the co-legislators (Parliament and Council) have empowered it to do so. The conditions for adoption are:
1. Gap condition — Harmonised standards under Article 40 do not exist, or they exist but are insufficient to cover the relevant AI Act requirements.
2. Consultation — The Commission must consult the AI Board (established under the AI Act) and relevant stakeholders before adopting common specifications.
3. Publication — Once adopted, common specifications are published and become available for providers to use.
Common specifications are not permanent replacements for harmonised standards. If a harmonised standard is subsequently developed and its reference published in the Official Journal, it takes precedence.
Presumption of conformity and the opt-out
Like harmonised standards, compliance with common specifications creates a presumption of conformity with the AI Act requirements they cover.
However, Article 41 includes an important opt-out: providers are not obligated to follow common specifications. A provider may use alternative technical solutions if it can demonstrate that those solutions achieve the same level of protection as the common specification.
In practice, the opt-out means: - The provider must document its alternative approach and the equivalence justification - The conformity assessment body (for systems requiring third-party assessment under Article 43) will scrutinise the equivalence claim - Market surveillance authorities may also challenge the claim post-market
The opt-out gives innovative providers flexibility but places a higher evidential burden on them compared to simply following the common specification.
Relationship to harmonised standards
Article 41 and Article 40 form a two-tier system:
| | Harmonised standards (Art. 40) | Common specifications (Art. 41) | |---|---|---| | Developed by | CEN, CENELEC, ETSI | Commission (implementing acts) | | Trigger | Commission request to standardisation bodies | Gap or insufficiency in harmonised standards | | Presumption of conformity | Yes | Yes | | Provider opt-out | Always (standards are voluntary) | Yes, with equivalence demonstration | | Priority | Primary mechanism | Fallback mechanism |
The AI Act's preference is for industry-led harmonised standards. Common specifications are a safety net ensuring providers always have a path to presumption of conformity, even when standardisation is delayed.
How Article 41 connects to the broader framework
- Article 40 — Harmonised standards: the primary conformity path that common specifications supplement.
- Article 8 — General compliance obligation for high-risk AI systems.
- Article 43 — Conformity assessment procedures where common specifications may be used as evidence.
- Article 113 — Application dates.
Compliance checklist
- Check whether common specifications have been adopted for any AI Act requirements relevant to your system.
- If using common specifications, document compliance with each applicable provision and retain evidence.
- If opting out of a common specification, prepare a detailed equivalence analysis demonstrating your alternative meets the same level of protection.
- Monitor the Official Journal for both new common specifications and new harmonised standards that may supersede them.
- Factor common specifications into your conformity-assessment planning — your notified body will need to assess against them (or your equivalence case).
- Track AI Board opinions and stakeholder consultations that may signal upcoming common specifications.
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Frequently asked questions
Are common specifications mandatory?
No. Providers may choose to follow common specifications for a presumption of conformity, or they may use alternative solutions if they can demonstrate those solutions achieve the same level of protection.
How do common specifications differ from harmonised standards?
Harmonised standards are developed by European standardisation bodies (CEN/CENELEC) through industry-led consensus processes. Common specifications are adopted directly by the Commission through implementing acts. Both provide a presumption of conformity, but common specifications are a fallback used when harmonised standards are unavailable or insufficient.
What if I comply with a common specification but a harmonised standard is later published for the same requirement?
You may continue relying on the common specification, but the harmonised standard takes precedence in the compliance framework. Transitioning to the harmonised standard is advisable as it reflects broader industry consensus and may be more readily accepted by conformity assessment bodies.