What are the CE marking regulations and directives?
Sep 09, 2022
Before you can affix the CE marking to your product, you have to comply with the regulations and directives drawn up by the EU. The standards for these legislative pieces have been outlined in the European harmonised standards of the European Commission.
Regarding CE marking regulations and directives
It is best practice to follow the rules laid out in the harmonised standards, but you can also find your own route to conformity. Make sure to follow the CE marking process for a smooth path to compliance.
Before you can establish which CE marking legislation to look at, you should check what rules apply to your product. Below is a list of fourteen CE marking regulations and directives that are relevant to a great number of products for affixing the CE marking.
For machinery the following directives apply: the Machinery Directive, the Low Voltage Directive, the EMC Directive and the Pressure Equipment Directive. Always make sure to check for new or amended directives and regulations.
Machinery Directive
2006/42/EC
The Machinery Directive is put in place to cover safety of machinery as well as safety components, chains, ropes and more. Different elements of these products should comply with the directive, amongst which mechanical design, electrical design and the controls. The directive provides an outline of how to reach conformity.
Low Voltage Directive
2014/35/EU
The Low Voltage Directive was created to ensure products within the EU adhere to certain voltage limits. The directive defines which electrical equipment and components should meet certain safety requirements.
EMC Directive
2014/30/EU
The EMC Directive regards electromagnetic compatibility. This CE marking directive has been drawn up to allow apparatus to move freely throughout the EU and to guarantee a satisfactory electromagnetic environment.
Pressure Equipment Directive
2014/68/EU
The Pressure Equipment Directive ensures stationary pressure equipment can be circulated within the EU and be safe at the same time. The directive states different categories, from I to IV. A category of II and above requires a Notified Body for compliance.
Cableway installations Regulation
Regulation (EU) 2016/424
The goal of this CE marking regulation is to ensure that cableways that carry passengers have the essential requirements in terms of safety, design, construction and entry into service.
Personal Protective Equipment Regulation
Regulation (EU) 2016/425
This EU regulation has been put in place to ensure personal protective equipment is safe to use and has the right design and manufacture.
Medical Devices Directive
93/42/EEC
This directive outlines the requirements for medical devices in order to be moved freely within the EU. This directive applies to medical devices, such as instruments, appliances and materials that are used on human being for medical purposes.
Currently, there are proposals pending regarding possible amendments to this directive.
REACH – Regulation
Regulation (EC) No 1907/2006
REACH is the acronym for Registration, Evaluation, Authorisation and Restriction of Chemicals. In short: producers of chemical substances should register safety data, a higher volume of chemicals should be evaluated on safety, ‘very high concern’ chemicals should be phased out and replaced with safer alternatives and some chemicals may be banned or the usage can be restricted.
Construction Products Regulation
Regulation (EU) No 305/2011
This CE marking regulation is mandatory so construction products that are placed on the internal market of the EU meet specific health, safety and environmental rules. Amongst the requirements are that construction products should have mechanical resistance and stability, should be safe in case of a fire and should have a sustainable use of natural resources.
Gas Appliances Regulation
Regulation (EU) 2016/426
This CE marking regulation regards the burning of gaseous fuels. Amongst the requirements for CE marking are that: appliances in this category should be accompanied by technical instructions and the appliances and fittings should be energy efficient.
RoHS Directive
2011/65/EU
RoHS is the acronym for Restriction of Hazardous Substances. This directive involves legislation for the use of these substances in electrical and electronic equipment. It is meant to ensure safe usage and an environmental-friendly disposal of waste.
Measuring Instruments Directive
2014/32/EU
This CE marking directive is meant to guarantee a high level of protection for the public when it comes to measuring instruments. Think of products such as water meters and thermal energy meters.
Toy Safety Directive
2009/48/EU
Items such as teddy bears and other toys should adhere to the safety measures of the EU. It deals with toys made for children under 14. This directive does not apply to every toy. Toy steam engines and slings are, for instance, excluded.
Lifts Directive
2014/33/EU
Specific standards apply for the construction and design of lifts that are used in buildings and constructions. This CE marking directive applies to both lifts for persons and goods. Several appliances that are of importance for the construction of a lift also fall under this directive.
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