Navigating the CE Mark process can be a challenge for both startups and experienced manufacturers alike. This article is a guide for hardware manufacturers who want to do all the right things to legally get their product into Europe.
Here’s what we’re going to cover:
- The typical CE Marking process for electronic equipment
- Outline of the most common directives
- How to find the standards that apply to your product
- Documentation requirements
Disclaimer: There are many caveats and nuances to the CE Mark process. Do not rely solely on the contents of this article to navigate the process. Always contact an accredited test lab or notified body for advice specific to your product.
I just want to preface this article by stating that it’s very possible to import products into Europe the illegal way or the legal way. An official report on market surveillance of electronic products in Europe undertaken in 2012 (based on a sample size of approximately 10,000 products) showed that approximately 2/3 of equipment was non-compliant with the rules. That included both technical and documentation issues.
There are clearly a high number of non-CE compliant devices entering Europe. So why bother? Really the two reasons are liability and liability. The first type of liability comes about if a competitor or a consumer lodges a compliant that your product is non-compliant in some way. You run the risk of fines, product recalls and shipments being blocked at the border.
The second type of liability is if your product is found to be unsafe in some way and actually causes damage or an accident. If you ever get dragged into court, having a safety test report on hand would probably come in handy to prove that you did some sort of due diligence around safety compliance.
But this article is really for the manufacturers who prefer to avoid liability, do things by the book and have a repeatable process in place for efficiently meeting conformity requirements.
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 – TOP LEVEL 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 [Note that there are alternative routes to compliance that do not involve the use of 3rd party test labs, but those are outside the scope of this article. If you’re interested in reading more on these alternative routes, check out this in-depth article on the subject by Keith Armstrong.]
- Draw up and keep available the required technical documentation
- 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. I’m going to go through these step by step below:
1. 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”, which we’ll get into below.
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 and Low Voltage Directive (safety) no longer apply. 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.
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.
The WEEE Directive (Waste from Electrical and Electronic Equipment Directive) is now applicable to most electronic and electrical equipment in Europe. It’s aimed at redirecting waste electronic and electrical equipment from the landfill to a recycle depot instead.
As a manufacturer, you have some obligations under this directive, including:
- Marking your equipment with the WEEE logo
- Joining a PCS (producer compliance scheme) – this is to finance the collection and recycling scheme.
- Providing information to a PCS on items such as product sales
Even manufacturers who are based outside of the EU are required to join a PCS in every member state (country) that their product is sold into! Whether that is actually happening or not, is up for debate.
There are lots of other directives that could potentially apply to your product depending on the type and application of product. Some of the other directives include:
- The machinery directive
- Active implantable medical devices directive
- The medical device directive (MDD)
- ECO design
- ATEX Directive (Equipment and protective systems for potentially explosive atmospheres)
- Toy safety directive
2. HOW TO FIND THE STANDARDS THAT APPLY TO YOUR PRODUCT
It’s often a challenge to work out exactly which standards and directives apply to your product. Here are some ideas for tracking them down:
- Call a 3rd party test lab and request a test plan
- Check your competitor’s documentation/datasheet using Google. If you’re lucky, they have published their declaration of conformity
- Find them yourself (outside the scope of this article)
Having the latest standards in hand is very useful for working out what you actually have to comply with. Without them, you’re running blind to a certain extent and run the risk of failing tests or requirements that you haven’t prepared for.
Where to find and buy EMC/RF/Safety Standards
Standards can be very expensive. Before spending >€200 per standard, I recommend visiting the Estonian Centre for Standardization (https://www.evs.ee/shop) where many standards are available for under €30. Most radio standards are available for free from http://www.etsi.org.
3. VERIFY PRODUCT SPECIFIC REQUIREMENTS
Once you’ve identified all of the standards that apply to your product, you need to work out a few things:
- Which specific tests apply;
- What the test configurations are;
- What test levels apply (immunity);
- What emissions limits apply (radiated & conducted emissions);
- What pass criteria you need to meet;
This is all stuff that a test lab will need to collate when they create your ‘test plan’.
4. IDENTIFY WHETHER AN INDEPENDENT CONFORMITY ASSESSMENT (BY A NOTIFIED BODY) IS NECESSARY
Depending on your product type, you may need to involve a notified body to conduct a conformity assessment. If you have a relatively risky product such as a medical device or non-standard radio transmitter for example, then you’re more than likely going to need to go this route.
5. TEST THE PRODUCT AND CHECK ITS CONFORMITY
This is the part that everyone hates! It’s usually the part where you send your product away to a 3rd party test lab for testing. It costs a fortune, it can take ages, and the failure rate is often over 50% (at least for EMC).
Assuming you’re going the harmonized standards route to compliance rather than alternative routes, you’ll need to modify your product and/or documentation until you pass the applicable tests. You can’t sell your product until you do!
6. THE TECHNICAL FILE
Each of the directives that apply to your product have their own documentation requirements. Basically, the technical file needs to include all of the information and technical documents that a 3rd party would need to be able to successfully verify that your product is compliant with the requirements of the directive.
In general, the technical file needs to contain at least the following documents to satisfy each applicable directive:
- A general description of the apparatus such as conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc. As well as descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment
- An adequate analysis and assessment of the risk(s) involved
- Evidence of compliance with the harmonised standards, if any, applied in full or in part; including fixes required to conform with standards
- Results of design calculations made, examinations carried out, etc.,
- Test reports
- Statements from notified bodies (if applicable)
You as the manufacturer or your authorized representative located within Europe should keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.For more on this, check out the European Commission’s website and the “Red Book” guide.
7. CE MARK & DECLARATION OF CONFORMITY
The CE Mark DoC
Now that you’ve proven compliance with the rules, it’s time to draw up a declaration of conformity. The Declaration of Conformity is a special document that the manufacturer signs to say that the prod-uct meets all of the requirements of the applicable directives. It must be issued by the manufacturer, and it states that the manufacturer is solely responsible for the conformity of the product.
The Declaration of Conformity must include (at least):
- a reference to the applicable Directive(s), standards and provisions complied with,
- an identification of the apparatus (name, type, model number and any relevant supplementary information),
- the manufacturer’s details such as name and address,
- a dated reference of the specifications under which conformity is declared
- the date of the declaration,
- the identity and signature of the person empowered to bind the manufacturer or his authorised representative.
- the statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, his authorised representative.
- Name of the notified body (if applicable)
In the new “Blue Book” guide to implementation of EU product rules, it states that, “A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU declaration of conformity.”
The CE Mark “Sticker”
Once the necessary steps have been successfully completed, the CE marking must be affixed to the product and packaging. This isn’t to be con-fused with the infamous “China Export” mark! The marking must be placed visibly and legibly on the product or, if not possible due to the size/nature of the product, be affixed to the packaging and the accompanying documentation. Good luck on your next product!
Originally published on EMC FastPass.