Our product failed an EMC test

The EMC Directive 2014/30/EU sets two essential requirements for equipment. The electromagnetic disturbance it generates must not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended, and it must have a level of immunity to the disturbance expected in its intended use that lets it operate without unacceptable degradation (Annex I, point 1). Equipment may be made available or put into service only if it complies when properly installed, maintained and used for its intended purpose (Article 4).^[1]

A failed test is a failed conformity assessment. The manufacturer draws up the technical documentation and carries out internal production control or EU-type examination, and only where compliance has been demonstrated does it draw up the EU declaration of conformity and affix the CE marking (Articles 7(2) and 14). The assessment must cover all normal intended operating conditions and, where the apparatus can take different configurations, all configurations identified as representative of its intended use (Annex II, point 2).^[1]

Harmonised standards are the usual yardstick, not the law itself. Equipment that conforms with harmonised standards published in the Official Journal is presumed to meet the essential requirements those standards cover (Article 13). If the product fails the standard, the presumption is gone, and the manufacturer must either fix the product or demonstrate compliance another way, for example with EU-type examination by a notified body for some or all aspects (Article 14).^[1]

Units already on the market must be dealt with. A manufacturer that considers or has reason to believe that apparatus it placed on the market is not in conformity immediately takes the corrective measures needed to bring it into conformity, or withdraws or recalls it, and where the apparatus presents a risk informs the authorities where it was made available (Article 7(8)). Where apparatus presents a risk, authorities that find non-compliance require corrective action within a reasonable period and take provisional measures if the operator does not act (Article 38); formal non-compliance is dealt with under Article 40.^[1]

Radio equipment is the exception. Equipment covered by the Radio Equipment Directive meets the EMC requirement through Article 3(1)(b) of that directive, which refers to the level of electromagnetic compatibility set out in Directive 2014/30/EU.^[3]