C
Conformity Assessment
Definition
A conformity assessment is the process by which a manufacturer evaluates and demonstrates that an EEE product meets the requirements of the RoHS Directive 2011/65/EU before placing it on the EU market. Under RoHS Article 8, the conformity assessment procedure involves: conducting the assessment (material testing, supplier declarations, analysis); compiling the Technical Documentation (per Annex VI or EN IEC 63000:2018); drawing up a Declaration of Conformity (DoC); and affixing the CE marking. Unlike some EU directives, RoHS does not require involvement of a third-party Notified Body — it is a manufacturer self-declaration process.
Source
Directive 2011/65/EU, Articles 8–15 and Annex VI.
Practical Explanation (Compliance Context)
RoHS conformity assessment is a manufacturer’s internal process — no external Notified Body is required. However, the quality of the conformity assessment is tested during market surveillance audits. Best practice is to follow EN IEC 63000:2018 (Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances) as the framework for collecting, organising, and validating compliance evidence. Conformity assessment must be re-evaluated when the product design, materials, or applicable exemptions change.