EMC Directive Harmonised standards and deviations

Article 13 of Directive 2014/30/EU gives the core rule: equipment conforming with harmonised standards, or parts of them, whose references are published in the Official Journal of the European Union is presumed to conform with the Annex I essential requirements covered by those standards or parts.

That wording matters. The presumption is tied to the published reference, the cited parts of the standard, the essential requirements covered by those parts, and the product facts at the moment the apparatus is placed on the market. It does not automatically cover every EMC phenomenon, every configuration, every operating mode, or every later version of a standard.

For a useful compliance record, identify the apparatus, intended electromagnetic environment, applicable essential requirements, OJEU-cited standard references, exact editions and amendments applied, and any gaps that need a separate EMC assessment.

Commission Implementing Decision (EU) 2019/1326 publishes references of EMC harmonised standards listed in Annex I and withdraws references listed in Annex II from the dates shown there. The grounded consolidated decision is dated 10 June 2022 and includes amendments through Implementing Decision (EU) 2022/910.

Examples of cited Annex I references in that consolidated decision include EN 55035:2017 with A11:2020 for multimedia equipment immunity, EN 55011:2016 with A1:2017 and A11:2020 for industrial, scientific and medical equipment radio-frequency disturbance characteristics, EN 55014-1:2017 with A11:2020 for household appliances, electric tools and similar apparatus emission, EN IEC 55015:2019 with A11:2020 for electrical lighting radio disturbance characteristics, and EN 55032:2015 with A11:2020 for multimedia equipment emission.

The same decision also lists withdrawn references and withdrawal dates. For example, EN 55032:2012 with AC:2013, EN 55011:2009 with A1:2010, EN 55014-1:2006 with amendments, and EN 55015:2013 are listed with a withdrawal date of 4 May 2022 in the grounded consolidated decision. A technical file should therefore show which reference was relied on when the apparatus was placed on the market and whether any transition or withdrawal issue was reviewed.

A deviation is not automatically forbidden, but it weakens the shortcut that a clean, relevant, OJEU-cited standard normally provides. The EMC guide states that the secure route is to apply the relevant cited standards without deviation while making the EMC assessment; if the manufacturer deviates, the technical documentation should give detailed information on those deviations.

Common deviation cases include skipping tests, changing the standard test method, relying on design precautions or comparison with similar apparatus, applying only emission or only immunity coverage, using an older withdrawn reference, or using non-harmonised EMC specifications because no harmonised standard covers the technology or environment.

For each deviation, document the specific clause or test not followed, the reason, the alternative evidence, the EMC phenomenon affected, the intended environment, the conclusion against Annex I, and the person approving the residual risk. Do not describe a product as covered by a harmonised standard without making clear which parts were applied and which parts were justified separately.

The technical documentation should make the EMC conformity argument readable without reconstructing the project history. At minimum, keep product identification that links the apparatus, EU declaration of conformity and technical documentation; the dated list of harmonised standards applied; the results obtained from applying them; and the EMC assessment for any essential requirements not covered by harmonised standards or not covered because the standard was used only in part.

The Directive requires manufacturers to keep the technical documentation and EU declaration of conformity for 10 years after the apparatus has been placed on the market. Importers must keep a copy of the EU declaration of conformity for the same period and ensure the technical documentation can be made available to authorities on request.

The evidence set should also include test reports, worst-case configuration rationale, intended-use and environment assumptions, residential-use restrictions where relevant, other technical specifications used, notified-body material if Annex III was chosen, and change-control records for design changes or standard changes affecting the conformity claim.