Glossary · Machinery law and conformity
Presumption of conformity
German: Konformitätsvermutung
In EU product law, presumption of conformity is the legal effect by which applying a harmonized standard whose reference is cited in the Official Journal of the European Union may support conformity with the legal requirements that the standard covers. The presumption is limited to those requirements and can be rebutted.
- Compliance
- EU
- German source term
In one sentence
Presumption of conformity lets a manufacturer rely on a cited harmonized standard, but only for the legal requirements that standard actually covers.
Example
A press builder applies the harmonized type-C standard for mechanical presses; the presumption covers the essential requirements listed in its Annex ZA, while hazards outside that table still need their own justification.
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
- The Radio Equipment Directive: when sector law absorbs aspect requirementsWhy does the cybersecurity part of the Radio Equipment Directive create parallel compliance paths?UKDeutsch
- Machinery Regulation and CRA: coupled through standards, not cross-referencesWhy can the Machinery Regulation and the Cyber Resilience Act not simply refer to each other?UKDeutsch
- EN 50742: safety-related security levels and IEC 62443 working togetherIs EN 50742 a sign that legislators misunderstand technicalities, and do its SRSLs contradict IEC 62443?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
- BSI guidance on the CRA: context-dependent, not contradictoryWhen two pieces of BSI guidance on the Cyber Resilience Act seem irreconcilable, is the guidance contradictory?UKDeutsch
How it applies
- Compliance: The presumption only arises for standards whose reference is published in the Official Journal under the relevant legal act, and only for the requirements the standard is mapped to, usually in an informative annex (Annex ZA or similar). Check the citation and the edition before relying on it.
- Limits: It is a presumption, not proof. An authority can still show that a product is unsafe, and hazards the standard does not address need their own assessment against the law.
- Technical documentation: The technical file should list the harmonized standards applied, the edition, and which requirements each one is used for. Partial application must be stated as such.
- German nuance: Konformitätsvermutung is used in the same legal sense; German practice often stresses that it shifts the burden of proof rather than replacing the manufacturer's own risk assessment.
Presumption of conformity vs. compliance
Using a harmonized standard is voluntary and is one way to demonstrate conformity. Compliance itself still depends on meeting the applicable requirements for the specific product and its intended use. The same mechanism exists under the EU AI Act, where conformity assessment (AI Act) can rely on harmonized standards once they are cited. For AI functions of machinery, Article 20(10) of the Machinery Regulation lets AI Act harmonized standards support the presumption until machinery-specific ones exist, and under the ESPR the harmonized DPP standards do the same for the digital product passport requirements they cover.