Conformity assessment
The process of showing that a product meets the EU rules that apply to it before it is placed on the market.
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What it is.
Under EU product law a manufacturer may place a product on the market only when it meets all the requirements that apply. Conformity assessment is how that is shown. Depending on the law and the risk, it can mean internal checks and technical documentation, or testing and certification by an independent notified body.
Once the right procedure is complete, the product can carry the CE mark. The EU AI Act uses the same idea for a high-risk AI system, and EU medical device rules use it for many devices, including some software.
Why it matters
For software in a regulated category, conformity assessment shapes the whole project: what documents you keep, how you manage risk, how you test and how you handle changes after launch. Planning for it from the start avoids rebuilding evidence at the end.
In a product build
We keep the evidence as part of normal delivery: requirements traced to tests, versioned design records, risk logs and release notes. For AI systems that also means evals, logs of model versions and human-in-the-loop controls that can be shown to an assessor.
Common mistakes.
- 01
Treating it as a form filled in at the end rather than evidence built during the project.
- 02
Assuming a voluntary certificate counts. Only notified bodies can certify where the law requires one.
- 03
Forgetting that significant changes after launch can need a new assessment.
Read the official text.
Primary sources this definition is based on.
- European Commission, Conformity assessmentchecked 2026-10-25
- Regulation (EU) 2024/1689, the AI Act (Official Journal)checked 2026-10-25
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Related terms.
- High-risk AI system (EU AI Act)An AI system the EU AI Act places in its high-risk class, which brings extra duties before and after it is placed on the market.
- SaMD (software as a medical device)Software meant for one or more medical purposes that does that job on its own, without being part of a hardware medical device.
- GxP (good practice regulations)The family of good practice rules, such as manufacturing (GMP), clinical (GCP) and laboratory (GLP) practice, that regulated life sciences work must follow.
- Audit trailA secure, time-stamped history of who created, changed or deleted a record, kept so the record can be trusted later.
- LLM evals (evaluations)Repeatable tests that score how well a model, prompt or AI feature does a specific task.
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