Machinery Regulation EU 2023/1230
The Machinery Regulation provides product regulations for machines and installations. A new machinery Regulation EU 2023/1230 was published on 29 June 2023. The regulation will enter into force 20 days after this date (19 July 2023). From January 14, 2027 the Machinery Directive 2006/42/EC will be repealed and only new Regulation will be valid. In...
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Implementing Regulation (EU) 2021/2078
Read complete text of the Implementing Regulation EU 2021/2078 related to EUDAMED - European Database on Medical Devices.
Implementing Regulation (EU) 2021/2226
Are you a manufacturer of a medical device? In that case, since January 2022 it has been possible under certain conditions to provide instructions for use exclusively in electronic form. The conditions under which this is possible can be found in Implementing Regulation (EU) 2021/2226. In our knowledge base you will find more information about...
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General Product Safety Directive 2001/95/EC
The General Product Safety Directive 2001/95/EC applies to consumer products that are covered by no specific CE marking legislation. Although it is not mandatory to affix a CE marking to these products, manufacturers must meet the safety requirements of the General Product Safety Directive. In accordance with the General Product Safety Directive manufacturers are required...
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Low Voltage Directive 2014/35/EU
The Low Voltage Directive 2014/35/EU applies to electrical equipment intended for a nominal alternating voltage between 50V-1000V or a nominal direct voltage between 75V-1500V. Manufacturers who are planning to place electrical equipment on the EU market, must meet the product safety requirements of the Low Voltage Directive. Manufacturers must see to it that the health...
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EMC Directive 2014/30/EU
The EMC Directive 2014/30/EU is focused on the electromagnetic compatibility (EMC) of electrical and electronic equipment. This means that the equipment is manufactured in such a manner that it will be able to function without causing electromagnetic disturbances to other devices in its environment. Manufacturers who are planning to place electrical and electronic equipment, such...
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RoHS Directive 2011/65
The RoHS Directive 2011/65 contains regulations regarding the restrictions on the use of hazardous substances in electrical and electronic equipment. Electrical and electronic equipment are devices that operate on electrical currents or electromagnetic fields with a voltage of up to 1 000 volrs at alternating current or 1 500 volts at direct current. The RoHS...
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Medical Device Regulation 2017/745
Medical devices, accessories of medical devices and medical software must comply with all the relevant design, safety and performance requirements, in accordance with the Medical Device Regulation 2017/745. In order to define a product as a medical device, it must first be classified based on a risk classification. Depending on the main purpose and the...
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Machinery Directive 2006/42/EC
The Machinery Directive 2006/42/EC contains product requirements for machinery and installations. These product requirements are included in essential safety and health requirements. Manufacturers who are planning to place machinery and installations on the EU market, must comply with these requirements and must conduct a risk assessment in order to confirm which safety and health requirements...
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Regulation Construction Products 305/2011
The Regulation Construction Products 305/2011 is focused on the safety of construction products. Construction products that are placed on the EU market must meet the essential characteristics. These characteristics are laid down in harmonised technical specifications with regard to the basic requirements for construction works. The basic requirements refer to: mechanical resistance and stability, fire...
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The Pressure Equipment Directive 2014/68/EU
The Pressure Equipment Directive 2014/68/EU describes the safety requirements for pressure equipment, with regard to, amongst others, its maximum pressure, maximum temperature and maximum internal volume. Some examples of pressure equipment are: pressure cookers, installation pipes and waste incineration boilers. Manufacturers of pressure equipment must meet the essential safety requirements of this Directive. Pressure equipment...
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The Radio Equipment Directive (RED) 2014/53/EU
The Radio Equipment Directive (RED) 2014/53/EU applies to electrical or electronic products that intentionally emit and/or receive radio waves, such as televisions, mobile phones and Wi-Fi equipment. Manufacturers of radio equipment must meet the requirements of this Directive. However, they should also ensure the safety of persons and domestic pets, as set out in the...
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Personal Protective Equipment Regulation 2016/425
The Personal Protective Equipment Regulation 2016/425 (PPE) applies to products that are intended to be worn or held by a person as protection against one or more hazards that may a pose a threat to his health or safety. Manufacturers of PPE must meet with the essential safety requirements of this Regulation. The PPE are...
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ATEX Directive 2014/34/EU
The ATEX Directive 2014/34/EU is applicable to equipment, protective systems and components intended for use in a potentially explosive atmosphere (ATEX). Manufacturers who are planning to place these products on the market, must take the safety and health requirements of the ATEX Directive into account. These requirements are, amongst others, aimed at the integrated explosion...
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Toys Safety Directive 2009/48/EC
The Toys Directive 2009/48/EC is focused on the safety of toys. Toys that are placed on the EC market must comply with the essential safety requirements of this Directive. These requirements are aimed at the physical, mechanical, chemical and electrical properties of toys. The Toys Directive also imposes requirements regarding the flammability, hygiene and (if...
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