EU RoHS Directive CE marking and DoC

Directive 2011/65/EU applies CE marking and EU Declaration of Conformity duties to electrical and electronic equipment within RoHS scope. Before signing, confirm that the finished EEE has evidence showing that Article 4 restrictions have been met in each homogeneous material, including any valid exemption relied on.

The manufacturer draws up the required technical documentation, carries out or has carried out internal production control under Module A, issues the EU Declaration of Conformity, and affixes the CE marking once conformity has been demonstrated. The Directive permits one technical-documentation set when another applicable EU law uses a conformity-assessment procedure that is at least as stringent, but the file and declaration must still cover the RoHS requirements. Module A covers design and production: the manufacturer prepares the technical documentation and performs the checks needed to demonstrate conformity, without requiring a notified conformity-assessment body for that module.

The CE mark is the manufacturer's indication that the finished product meets the applicable Union harmonisation requirements. It is not a separate RoHS certificate issued by the Commission, a laboratory, or a supplier. A combined declaration can cover RoHS and other applicable Union acts, but each act needs its own supported conformity conclusion.

A RoHS DoC should not be signed from a marketing claim alone. The file needs enough traceable evidence to show that the finished EEE was assessed against the restricted substances, threshold structure, and any applicable exemption position. RoHS Annex II lists maximum concentration values by weight in homogeneous materials, so bill-of-materials (BOM) evidence has to resolve below product level where necessary.

EN IEC 63000:2018 is the harmonised standard identified by Commission Implementing Decision (EU) 2020/659 for technical documentation used to assess materials, components, and electrical and electronic equipment against RoHS restrictions. Use of a cited harmonised standard is voluntary and can support presumption of conformity for the covered documentation requirement; it is not a product certificate or a substitute for the underlying material assessment.

Importers and distributors must perform their own RoHS checks. Before placing EEE on the EU market, importers must ensure the manufacturer has carried out the appropriate conformity-assessment procedure, drawn up technical documentation, applied CE marking, supplied required documents, and met identification and contact-information duties.

Distributors must act with due care when making EEE available on the market. For RoHS, that includes checking that the EEE bears CE marking, is accompanied by required documents in a language understandable to consumers and other end-users in the relevant Member State, and that manufacturer and importer identification duties have been met. An importer or distributor that places EEE on the market under its own name or trademark, or modifies EEE in a way that may affect compliance, is treated as the manufacturer for RoHS purposes.

The RoHS file has to remain useful after launch. Manufacturers must keep the technical documentation and EU Declaration of Conformity for 10 years after the EEE has been placed on the market. Authorised representatives may be mandated to keep those documents available to national surveillance authorities for the same 10-year period.

RoHS also requires procedures for series production to remain in conformity, taking account of changes in product design or characteristics and changes in harmonised standards or technical specifications used for the declaration. Reopen the controlled DoC and its supporting file when the product, supplier evidence, restricted-substance assessment, exemption position, or cited standard changes.