The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. To use the CE mark on a product, the manufacturer must draw up an EU Declaration of Conformity (DoC) in which the manufacturer attests to conformity with all relevant New Approach Directives (NADs) and takes sole legal responsibility, also called self-certification. In some instances, a NAD may require a Notified Body to issue a Certificate of EU Declaration of Conformity (DoC) to verify the performance of the product or the constancy of the production process (Factory Production Control, for example).
There are numerous directives that products placed on the market in Europe must comply with, however, manufacturers of electronic products have a small list of Directives that are typical, depending on product type.
Radio Equipment Directive 2014/53/EU (RED) – any product that contains a radio module or utilizes wireless technology will more than likely fall into this directive for compliance. “Radio equipment”, as defined in the new RED specifies: ‘radio equipment’ means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination
EMC Directive 2014/30/EU – the EMC Directive deals with ensuring that equipment functions satisfactorily in its electromagnetic environment without introducing unacceptable electromagnetic disturbances to other equipment in that environment. And it must be impervious to EMC from the environment and other equipment operating in the vicinity. The EMC Directive ensures the correct operation of equipment, that it adequately responds to electromagnetic phenomena, and the avoidance of any interference effects.
Low Voltage Directive 2014/35/EU – electrical products that have a voltage rating within the below parameters can be subject to the LVD:
- 50-1000 volts for AC devices
- 75-1500 volts for DC devices
Conformity to the LVD is mandatory if your product is within the voltage limits and not excluded by the law. LVD compliance is not assured by using all CE-marked components. That is the starting point and the device itself must carry a CE marking that indicates the overall assembly, tested and evaluated as a single unit, is in legal compliance with the Low Voltage Directive.
Machinery Directive 2006/42/EC – equipment that may fall into the Machinery Directive includes, besides machinery, the following:
- Interchangeable equipment
- Safety components
- Lifting accessories, chains, ropes, and webbing
- Removable mechanical transmission devices
- Partly completed machinery
Machinery is defined, broadly, as anything with linked components that move under other-than-human power. Think Electrical, Hydraulic, and or Pneumatic function.
The Machinery Directive is a law and requires that equipment within its scope is compliant with the applicable technical requirements listed in Annex I. These technical requirements are called the Essential Health and Safety Requirements (EHSR’s).
RoHS Directive 2011/65/EU – The Restriction of Hazardous Substances (RoHS) Directive is a CE marking Directive that applies to anything that is “EEE” or ‘electrical and electronic equipment’, essentially anything that has an electric function, even a gas powered lawn mower with a piezo spark ignitor. Products that fall under the scope of RoHS are found in Annex I of the RoHS Directive and the material restrictions that manufacturers must comply with are listed in Annex II. If your product is in the scope of the RoHS Directive, every individual component of your product (paint, screws, housings, labels, etc) must be independently compliant to the substance level restrictions in the RoHS Directive.
Please contact F2 Labs if you have any questions regarding your product’s need for CE compliance.