Conformity assessment is the process of demonstrating that a product meets applicable requirements. The permitted procedure depends on the legislation and product category; a laboratory report is one form of evidence, not a substitute for the complete procedure.
Available assessment procedures
The framework in Decision 768/2008/EC does not make every module available under every directive. LVD uses internal production control (A). EMC offers A or B+C. RED offers A, B+C in Annex III or full quality assurance (H) in Annex IV, subject to Article 17. MDR uses its own sector-specific procedures. Always check the law and product category before selecting a route.
Standards and their limits
Harmonised standards are generally voluntary. Applying an OJ-cited standard can provide a presumption of conformity only for the requirements it covers and subject to published restrictions. Under RED Article 17, missing or partly applied relevant standards for Article 3(2)/(3) require B+C or H for those requirements. Standards, accredited test laboratories and notified bodies have different roles.
The declaration and responsibility
The EU declaration of conformity is issued under the manufacturer’s responsibility, including when a notified body participates. Use the applicable legal model, identify the product and manufacturer, cite applicable legislation and specifications, and include the authorised signatory and any required notified-body reference. An authorised representative acts within a written mandate. Language and provision to users are law- and market-specific.
CRA product classification
CRA classification follows core functionality, Annexes III/IV and the technical descriptions in Regulation 2025/2392. Operating systems are important Class I; Class II includes firewalls/IDS/IPS, specified hypervisors/container runtimes and tamper-resistant microprocessors/microcontrollers. Smartcards and similar devices, including secure elements, are critical categories. Integrating such a component does not automatically give the complete product its category. Article 32 defines the applicable assessment routes.
Practical checklist
- Identify the product, intended use, market and applicable legal scope.
- Record the exact legal provisions, dates and applicable standard editions, including restrictions.
- Select the permitted assessment route and document the evidence needed.
- Link risk assessment, tests, product versions and declarations in the technical documentation.
- Assign responsibility for changes, support and responses to authorities.
This checklist supports planning; the applicable legal requirements determine the final assessment.