Directives and Regulations

A Directive is an EU legislative act that sets out a goal that all EU member states must achieve. (It is up to the individual countries to devise their own laws on how to reach these goals). The EU has issued Directives covering hundreds of subjects, most of which do not require the use of the CE Mark. Those Directives that do require the use of the CE Mark are commonly described as New Legislative Framework or NLF Directives.

In terms of CE Marking, a Directive and Regulation are very similar forms of legislation designed to broadly set out a framework to help manufactures achieve a safe product. Unlike safety Standards (BS, EN, IEC, etc.) they do not cover specifics but instead cover broad principles and processes that manufacturers should consider. Directives are intended to cover European markets and Regulations cover the GB market. The situation becomes slightly less clear-cut as the European Union is in the process of migrating from Directives to Regulations. Existing European directives are implemented into each member state’s laws, according to their own legal system. Member states may have different ways on how to interpret and integrate the directives. The introduction of the regulations, in the European market, are intended to restrict the variances between member states.

A product may fall within the scope of several directives, but it shouldn’t be too difficult to determine which ones apply. Directives such a medical device and ATEX (Potentially Explosive Atmospheres) apply to products based on their intended use or industry location. Machinery, Radio Equipment, EMC and Low Voltage directives apply to products based on their function and attributes. Most directives will have definition of their intended scope. For example, Low Voltage Directive puts upper and lower voltage limits on the products it is intended to cover.

Some directives can also be identified as ‘primary’ on products an influence how and what other directives should be considered. Radio Equipment Directive includes the need to consider EMC, but it also calls for the Low Voltage Directive to be addressed, but to ignore the voltage limits when it comes to scope of products.

To ‘show’ you have complied with a directive you should apply the CE mark in accordance with the guidance in the directive. Some directives require the issue of a support document (Declaration of Conformity, as an example) and these should be considered a legal statement made by the manufacturer prior to placement on the market. There are additional considerations for Importers and specialist product labelling, but as a ‘general rule of thumb’ the minimum they all require CE marking.

If your product falls under more than one Directive/ Regulation, the process of CE marking the product remains the same, but you may have to change the legal documentation, the Declaration of Conformity (DoC). Most of the safety directives follow the basic process of risk assessment, essential requirements, any standards referenced during the assessment, Operation/installation instructions and a DoC. The DoC must reference the directives you are claiming you comply with, product/model description, standards referenced, manufacturers address, date, and authorised person’s signature.

Directives in our Scope:

ATEX Product Directive 2014/34/EU

Electromagnetic Compatibility Directive 2014/30/EU

Low Voltage Directive 2014/35/EU

Machinery Directive 2006/42/EC

Machinery Regulations (EU) 2023/1230

Radio Equipment Directive 2014/53/EU