- Official source identifying EN IEC 63000:2018 for RoHS technical documentation assessing materials, components, and EEE.
"technical documentation required for assessing materials"
Use RoHS scope rules to decide whether a product is electrical and electronic equipment, whether an Article 2 exclusion applies, and which Annex I category should be recorded.
This guide focuses on category 11 open scope, cables, spare parts, and the evidence a team should keep when classifying equipment under Directive 2011/65/EU.
Structured answer sets in this page tree.
Cited legal and guidance references.
An EU RoHS scope decision should answer three questions in order: is the item EEE, is it excluded by Article 2(4), and which Annex I category applies. Category 11 captures other EEE not covered by categories 1 to 10, so an open-scope review needs a documented category rationale instead of a generic 'electrical product' label.
Directive 2011/65/EU defines EEE as equipment that depends on electric currents or electromagnetic fields to work properly, or equipment for generating, transferring, or measuring those currents and fields, within the Directive's voltage limits. The Directive also defines dependent as needing electricity or electromagnetic fields to fulfil at least one intended function.
The Commission FAQ explains the practical effect: an electric function can bring the whole product into scope even when electricity is not the main energy source, if that function is intended and integrated. If the electric part is separable and fully functional on its own, document whether only that electric equipment is in scope.
Annex I lists 11 RoHS EEE categories: large household appliances; small household appliances; IT and telecommunications equipment; consumer equipment; lighting equipment; electrical and electronic tools; toys, leisure and sports equipment; medical devices; monitoring and control instruments including industrial monitoring and control instruments; automatic dispensers; and other EEE not covered above.
Category 11 is the open-scope category. The Commission FAQ states that all equipment placed on the market and meeting the EEE definition is within one of the 11 Annex I categories unless an Article 2(4) exclusion applies. That makes category 11 a residual category, not a shortcut for avoiding the category analysis.
RoHS 2 expanded scope over time. Article 4(3) states that substance restrictions applied from 22 July 2014 for medical devices and monitoring and control instruments, 22 July 2016 for in vitro diagnostic medical devices, 22 July 2017 for industrial monitoring and control instruments, and 22 July 2019 for other EEE that was outside RoHS 1 scope.
Article 2(4) exclusions remain part of the decision. Examples include equipment designed to be sent into space, specifically designed equipment installed as part of another excluded or out-of-scope equipment type, large-scale stationary industrial tools, large-scale fixed installations, certain means of transport, professional non-road mobile machinery, active implantable medical devices, certain photovoltaic panels, R&D-only equipment made available business-to-business, and pipe organs.
The Directive defines cables as cables under 250 V that connect EEE to an electrical outlet or connect EEE to each other. The Commission FAQ says cables are generally in scope from 3 January 2013 unless they belong to EEE or a combination of EEE outside RoHS scope; optical cables are treated as outside the EEE definition because they do not have electrical or electronic parts.
External cables sold separately need their own RoHS compliance route from the relevant date. External cables sold together or marketed for use with a specific EEE must meet material restrictions but can be covered by that EEE's DoC and CE marking. Internal wiring follows the EEE it belongs to and does not need separate CE marking or a separate DoC.
A useful RoHS category memo is short but specific. It should let a reviewer reconstruct the classification without asking the product team to remember design history, market channels, or old transition assumptions.
Keep the memo linked to the technical documentation set. Article 7 requires manufacturers to draw up required technical documentation and carry out internal production control; a category and open-scope memo helps explain why the product was treated as in scope, excluded, or category 11.
Use a structured RoHS category memo to connect product facts, Article 2 exclusions, Annex I category reasoning, cable and spare-part treatment, citations, owners, and review triggers.
"technical documentation required for assessing materials"
"draw up the required technical documentation"
"External cables placed on the market separately"