To sell most types of electrical or electronic products in the European Union (EU), electromagnetic compatibility compliance with EMC Directive 2004/108/EC is required.
To meet the essential requirements of the EMC Directive, testing to a particular standard or standards is voluntary, although recommended, as they can provide a presumption of conformity. Harmonized standards are featured in The Official Journal of the European Union (OJ). Each standard governs a particular type of equipment, such as laboratory, IT, or household. The standards determine the strength and the limits for tests used to evaluate the product. Engineers should use generic standards only when there is no family standard covering the product.
If a product is redesigned or if the standard expires, manufacturers can perform a gap analysis to see if the product needs to be re-tested. If not, the manufacturer can prepare documentation with justifications, explaining why re-testing is not necessary.
The directive requires all possible product configurations be included in the EMC assessment, although a worst case representative model may be sufficient to cover simpler versions. If the difference is not design-related, such as a product color or shape, this model can be excluded from the list.
A company needs to prepare technical documentation or declaration of conformity (DoC) in accordance with Annex IV. The file should include a general description, environments where it can be used, warnings, manuals, and test reports.
The following standards are a good reference on how to prepare a DoC: EN ISO/IEC 17050-1:2005 and EN ISO/IEC 17050-2:2005. CENELEC has also published a specific guide for the DoC: CENELEC Guide 16.
The directive requires manufacturers or their authorized representatives to hold the technical documentation for at least 10 years after the last manufacturing date.
To ensure that products are tested to the correct standards and are in full compliance, manufacturers might want to submit their technical file and EMC report to a Notified Body (NB) for review. If everything is in order and complete, it issues a statement of opinion to be included in the technical file.
MET Labs has been designated a Conformity Assessment Body (CAB) in accordance with the US-EU mutual recognition agreement. For the EMC and R&TTE Directives, MET can prepare Technical Construction Files and perform other Notified and Competent Body functions.
If a manufacturer tries to place a non-compliant product on the EU market, it could face penalties that range from removing the product from the market to liability for a fine and/or imprisonment.