What is the difference between a CE directive and a CE regulation?

Understanding the legislative complexities of the European Union can be a daunting task, however, in order to trade products in the EU, it is essential to understand the different health and safety requirements that your products must comply with

About CE Certification Regulations and CE Directives

Best practice is to follow the rules set out in harmonized standards, but you can also find your own path to compliance. Make sure you follow the CE marking process so that compliance is smooth.

Before deciding which CE marking regulations to look at, you should check the rules that apply to your product. Here is a list of 14 CE marking regulations and directives that are relevant to a large number of products that carry the CE mark.

For machinery, the following directives apply: Machinery Directive, Low Voltage Directive, EMC Directive, and Pressure Equipment Directive. Always make sure to check for new or revised directives and regulations.

CE - Machinery Directive

2006/42/EC

The Machinery Directive was implemented to cover the safety of machinery as well as safety components, chains, ropes, etc. The different elements of these products should comply with the directive, which includes mechanical design, electrical design, and controls. The directive outlines how to achieve conformity.

CE - Low Voltage Directive

2014/35/EU

The Low Voltage Directive was developed to ensure that products within the EU comply with certain voltage limits. The directive defines which electrical equipment and components should meet certain safety requirements.

CE - Electromagnetic Compatibility Directive

2014/30/EU

The EMC Directive deals with electromagnetic compatibility. This CE marking directive was developed to allow the free movement of equipment throughout the EU and guarantee a satisfactory electromagnetic environment.

CE - Pressure Equipment Directive

2014/68/EU

The Pressure Equipment Directive ensures that fixed pressure equipment can circulate within the EU while being safe. This directive specifies different categories from I to IV. Categories II and above require a Notified Body to comply.

CE - Ropeway Installation Regulations

Regulation (EU) 2016/424

The goal of this CE marking regulation is to ensure that ropeways that carry passengers have essential requirements in terms of safety, design, construction and putting into service.

CE – Personal Protective Equipment Regulation

Regulation (EU) 2016/425

This EU regulation was implemented to ensure that personal protective equipment is safe for use and has the correct design and manufacture.

CE – Medical Devices Directive

93/42/EEC

This directive outlines the requirements for the free movement of medical devices within the EU. The directive applies to medical devices such as instruments, electrical appliances and materials intended for medical purposes.

Currently, there are proposals pending for possible revisions to the directive.

CE – REACH – Regulation

Regulation (EC) No 1907/2006

REACH is an acronym for Registration, Evaluation, Authorization and Stricting of Chemicals. In short: chemical producers should register safety data, the safety of a large number of chemicals should be evaluated, "high concern" chemicals should be phased out and replaced with safer alternatives, and some chemicals may be banned or restricted from use.

CE - Construction Products Regulation

Regulation (EU) No 305/2011

This CE marking regulation is mandatory so that construction products placed on the internal market of the European Union meet specific health, safety and environmental rules. One of the requirements is that construction products should have mechanical resistance and stability, should be safe in the event of fire, and should use natural resources sustainably.

CE - Gas Appliances Regulation

Regulation (EU) 2016/426

This CE marking regulation deals with the combustion of gaseous fuels. The requirements for CE marking include: appliances in this category should be accompanied by technical instructions, and appliances and accessories should be energy efficient.

CE - RoHS Directive

2011/65/EU

RoHS is an acronym for Restriction of Hazardous Substances. This directive deals with legislation for the use of these substances in electrical and electronic equipment. It aims to ensure safe use and environmentally friendly disposal of waste.

CE - Measuring Instruments Directive

2014/32/EU

This CE marking directive aims to guarantee a high level of protection for the public when it comes to measuring instruments. Think of products like water meters and heat meters.

CE - Toy Safety Directive

2009/48/EU

Articles such as teddy bears and other toys are subject to EU safety measures. It concerns toys made for children under 14 years of age. The directive does not apply to every toy. For example, toy steam engines and slings are excluded.

CE - Lift Directive

2014/33/EU

Specific standards apply to the construction and design of lifts used in buildings and construction. This CE marking directive applies to lifts for both people and goods. Several electrical appliances that are important for lift construction also fall under this directive.

Key Differences Between CE Directives and CE Regulations

With directives, member states have more leeway in implementing the subject of the legislative act, and they can adjust the means of implementation and other necessary legislative measures at their own pace.

Regulations are more direct, rigid legislation. No further consideration is required or allowed for the implementation of EU regulations, they come into force immediately after being approved by the EU Parliament, regulations have unparalleled legislative powers over other components of EU law, directives have different legislative powers