What are CE Directives?

The New Approach Directives are designed to address the legal differences between the member states of the European Union and thereby eliminate technical barriers to trade, define health, safety and essential requirements, and translate the Council of Europe directives and harmonized standards of member states into their national requirements.

Third party intervention is not mandatory in the implementation of the New Approach Directives. Producers prepare and sign a declaration of conformity to the European Union at their own free will. The use of standards is voluntary. The CE Mark indicates the conformity of the products to the directives and standards and is affixed to the product by the manufacturer.

Directives are legal regulations adopted by the Council of Ministers of the European Union. It must be adapted and enacted by each member state to its domestic law. Harmonized standards are common standards used to determine compliance. Each member state needs to adapt these standards to national standards. However, as mentioned above, these standards do not necessarily apply.

The basic requirements of the Directives are the set of requirements that the products must meet to be placed on the market and must comply with them. The basic requirements define the results to be achieved or the risks to be addressed, but do not provide technical solutions for this. Producers are free to choose how these basic requirements will be met.

The New Approach Directives are mainly based on the following four basic principles: regulatory compliance, technology development and knowledge, voluntary standards and assumption of compliance with basic requirements.

The New Approach Directives refer to a broad range of products. For example, machines, building materials, toys and medical devices. It is also possible for a product to be covered by more than one directive. For example, the electromagnetic compatibility directive (EMC) and the low voltage directive (LVD) can be applied simultaneously.

Below is a list of the New Approach Directives currently in force:

• Radio equipment directive (RED) = 2014 / 53 / EU

• Low voltage directive (LVD) = 2014 / 35 / EU

• Electromagnetic compatibility directive (EMC) = 2014 / 30 / EU

• Medical devices directive (MDD) = 2007 / 47 / EC

• Directive on active implantable devices (AIMD) = 90 / 385 / EEC

• In vitro diagnostic medical devices directive (INVMD) = 98 / 79 / EC

• Machine directive (MD) = 2006 / 42 / EC

• Directive on the restriction of the use of certain hazardous substances (RoHS) = 2006 / 42 / EC

• Waste electrical and electronic equipment directive (WEEE) = 2012 / 19 / EU

• Batteries directive (BATTERY) = 2006 / 66 / EC

• Equipment directive for potentially explosive atmospheres (ATEX) = 2014 / 34 / EU

• EcoDesign requirements directive for energy-related products (ECODESIGN) = 2009 / 125 / EC

• Directive on the labeling of energy-related products (LERP) = 2010 / 30 / EU

• Directive on packaging and packaging waste (WASTE) = 2015 / 720

• General product safety directive (GPSD) = 2001 / 95 / EC

• Personal protective equipment directive (PPE) = 2016 / 425 / EU

• Toy safety directive (TOY) = 2009 / 48 / EC

• Directive on explosives for civil use (ECU) = 2014 / 28 / EU

• Pyrotechnic substances directive (PTA) = 2013 / 29 / EU

• Measuring instruments directive (MID) = 2014 / 32 / EU

• Non-automatic weighing instruments directive (NAWI) = 2014 / 31 / EU

• Ropeway installation directive (CWI) = 2016 / 424

• Safety components for lifts and elevators (LIFTS) = 2014 / 33 / EU

• Directive for simple pressure vessels (SPVD) = 2014 / 29 / EU

Our company also provides CE directives within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

CE directive services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.