Directives & Regulations

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...

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...

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...

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...