Glossary · Machinery law and conformity
Conformity assessment
German: Konformitätsbewertung
In EU product law, conformity assessment is the process used to demonstrate whether specified legal or technical requirements relating to a product are fulfilled. Depending on the product and legal act, the manufacturer carries it out alone (internal production control) or with a notified body.
- Compliance
- EU
In one sentence
Conformity assessment is the process that demonstrates whether a product fulfills specified requirements, by the manufacturer alone or with a notified body.
Example
For a standard conveyor, the manufacturer uses internal production control; for machinery listed in Annex I of the Machinery Regulation, such as certain presses, a notified body must be involved.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
- CRA product categories: default, important and criticalWhich CRA products need a notified body, and how many products fall into the stricter categories?UKDeutsch
- Module H under the CRA: BSI TR-03183-H builds full quality assurance on ISO/IEC 27001How can a manufacturer demonstrate CRA conformity through its processes rather than product by product, and what does BSI TR-03183-H add?UKDeutsch
How it applies
- Procedures: The applicable legal act defines the modules. Under the Machinery Regulation, most machinery follows internal production control; for the categories listed in its Annex I a notified body is involved (EU type-examination, full quality assurance or unit verification): always for Part A, and for Part B unless harmonized standards or common specifications have been fully applied.
- Evidence: The result rests on the technical file: risk assessment, design data, test reports and the list of standards applied. Applying a harmonized standard can support the presumption of conformity.
- Result: A signed declaration of conformity and the CE marking. The assessment is not a one-time event: changes to the product can require a new one.
Conformity assessment vs. conformity assessment (AI Act)
The machinery procedure assesses a product against health and safety requirements. Conformity assessment (AI Act) assesses a high-risk AI system against requirements such as data governance, human oversight, accuracy and robustness. For AI that is a safety component of machinery, the AI Act requirements are checked within the machinery procedure, not in a separate one.