EMC (CE) Certification

The Electromagnetic Compatibility Directive (EMC — 2014/30/EU) imposes a two-way requirement: equipment must NOT EMIT electromagnetic interference at a level that would disturb other devices around it (emission), and it must itself be able to operate as expected against interference from the environment (immunity). It is concerned not with the product's safety but with its compatible operation in the electromagnetic environment.

• Manufacturers of electrical and electronic equipment
• Manufacturers of industrial control and automation systems
• Manufacturers of IT equipment and power electronics
• Firms installing and integrating fixed installations
• Those importing these products into the EU

Mandatory for equipment within scope. When the manufacturer fully applies the harmonised standards, it can self-declare through internal production control (Module A); when it does not, or applies them only in part, it must choose the route involving a notified body's opinion (Module B — EU type examination). Radio equipment is outside EMC's scope; its EMC requirements are addressed within RED.

• Scope and definitions: apparatus, fixed installation, electromagnetic disturbance, immunity
• Essential requirements (Annex I): emission limits and the immunity level
• Radiated emission and conducted emission
• Immunity tests: ESD, radiated-field immunity, electrical fast transients (EFT/burst), surge, conducted RF, magnetic field, voltage dips and interruptions
• Specific provisions and documentation for fixed installations
• Conformity-assessment routes: Module A and Module B+C
• The EMC assessment and the content of the technical file

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The product's block diagram, wiring and earthing arrangement
• Critical-component and filter information
• The list of harmonised standards applied (e.g. EN 55032, EN 55035, the EN IEC 61000-6 series)
• Emission and immunity test reports
• The product's operating mode during testing and the definition of the performance criterion

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEMachinery Safety
• CELVD
• CERED
• CEMDR
• CEIVDR
• CEPED
• CESPVD
• CEATEX