The CE Mark Process for Electronic Manufacturers.
Navigating the CE Mark process can be a challenge for both startups and experienced manufacturers alike. The following steps should serve as a guide for hardware manufacturers who want to do all the right things to legally get their product into Europe.
What is the CE Mark?
The CE Mark (or CE Marking is actually the correct way to say it) is a conformity scheme that allows for the free flow of products between countries in the European Economic Area (EEA). A manufacturer has the responsibility to prove compliance with whatever rules apply to their product in Europe and in theory, the CE Mark shows that the manufacturer has done their due diligence and the product is compliant.
Get the CE Mark - Step-By-Step Process
This is the generic process that hardware manufacturers typically follow to undertake due diligence before applying the CE Mark to their products.
- Identify the applicable directive(s) and harmonized standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentations
- Affix the CE mark and draw up the EU Declaration of Conformity
These six steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
The most common applicable CE mark Directives
The directives are a series of legal acts. There are lots of them but you only need to comply with the ones that are applicable to your particular product.
It’s important to note that the directives don’t actually outline the test requirements that are required to prove conformance. Test requirements are contained within “harmonized standards”
If your product passes all of the tests outlined in the relevant harmonized standards, then your device is said to have a “presumption of conformity” with the directives.
Here are some of the most common directives that apply to electronic hardware products:
The EMC directive applies to almost all non-wireless electronic equipment. It covers the radiated and conducted emissions performance of electronic products as well as the radiated and conducted immunity performance. You’ll notice that Europe has the additional requirement of adequate ‘immunity’ performance compared to FCC requirements, which only specify emissions limits.
Safety (LVD – Low Voltage Directive)
The LVD, which is a safety directive, applies to almost all electrical equipment designed for use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. The lower voltage limits are removed for wireless devices, which essentially means every wireless device sold into Europe, even if it’s a tiny 5V DC, 1 mW Bluetooth transmitter, needs to be tested for safety.
However, even if the LVD is not applicable to your product, the EU rules clearly state that a product must be still be ‘safe’. Other directives such as the GPSD (General Product Safety Directive) may still apply.
Radio (RF Transmitters)
The “Radio Equipment Directive” (RED) superseded the older “Radio & Telecommunication Terminal Directive” and came into full effect in mid-2016. It applies to equipment, which intentionally transmits or receives radio waves for communications or radiodetermination, regardless of its primary function. It covers the radio characteristics and frequency allocation of wireless transmitters in Europe.
A point to note is that if your equipment falls under the RED, then the EMC Directive no longer applies. The essential requirements of those Directives are now covered by the essential requirements of the RED, with certain modifications. ETSI publishes separate EMC standards (available for free from ETSI.org) specifically for wireless devices, however for ICASA Type Approval you are required to comply with all 3 directives (EMC, RF and Safety)
An often-overlooked aspect of CE compliance is the RoHS directive. This directive governs the maximum concentrations of hazardous substances contained within products. Some examples of the concentration level limits, bases on weight within homogeneous materials are:
Lead: 0.1 %
This has a real effect on electronics manufacturers for the components and technology you choose to use. Lead free solder is now widely available, but it can really suck to work with. If you want to be in compliance with the rules, make sure that your components and manufacturing processes comply with the RoHS requirements.
Beware of fake CE markings