The majority of manufacturers importing into the EU are aware of the need to correctly CE Mark their products. This can be a frustrating exercise with the diversity of information being given through the internet. What to believe?

My intension is to provide guidance and reference the official EU web site, where documents can be obtained, FREE, along with guidance that sets out to explain the requirements of each Directive/Regulation. (Beware not all of the guidance documents provide a clear understanding)

Adding to the above objective, specific Directives/Regulations, applicable to machines, will be addressed to allow the reader to determine the exact requirements applicable to complete machines, (Machinery Directive also accommodates Incomplete Machines) quoting the actual EU documents in the explanation.

EN Harmonized Standards will be indicated, to direct the reader to appropriate assessment documents. The simplest machines is likely within the scope of three EU Directives;

2006/42/EC Machinery Directive
2014/30/EU Electromagnetic Compatibility
2011/65/EU Restriction of Hazardous Substances (RoHS)

WARNING: A large amount of information is being provided, this may result in an “information overload” for the uninitiated.

The first point to explain;
Most CE Marking directives aim to allow “Self Certification” in most cases. If your product does not fall within the scope requiring mandatory involvement of EU “Notified Body”, you the manufacturer can “Self Certify”. Providing, of course, you have met the mandatory requirements of all applicable CE Marking EU Directives.

(This principle was first introduced way back in 1973 with the introduction of the first “New approach” Directive – Low Voltage Directive 73/23/EEC).

It is important to first identify the applicable CE Marking EU Directive/Regulation for your product. The scope of each Directive/Regulation will determine if your machine is included in the requirements. Directives/Regulation can be reviewed and downloaded, Free, form the below referenced website.

Identifying the latest addition of the Directive/Regulation that is applicable can be found on the EU web site;

This is the ONLY web site that should be used and referenced when dealing with CE Marking.

www.ec.europa.eu

This is the ONLY web site that should be used and referenced when dealing with CE Marking.

One very helpful document is known as the “Blue Guide 2016 EN”;

The Guide to the implementation of directives based on the New Approach and the Global Approach (the ‘Blue Guide’) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

This document is 156 pages and would require a determined effort to read completely. It is a wonderful reference document and should be on hand to everybody involved with CE Marking.

All CE Marking Directive/Regulation has EU published Guidelines, that attempt to explain the requirements in detail, perhaps making the explanation understandable. (Machinery Directive 2006/42/EC guidance, edition 2.2, dated Oct 2019, is 465 pages). The guidelines for each Directive/Regulation can also be obtained from the above referenced web site.

Once the Directive/Regulation has been identified, the appropriate compliance strategy needs to be determined.

All of CE Marking Directives/Regulations require the manufacturer to generate a Technical File to demonstrate and justify the product meets the requirements of the directive. The content of each Technical File is detailed in each CE Marking Directive/Regulation. One of the routes open to the manufacturer is to use an EU Harmonised Standards.

CE Marking Directives/Regulations publish a list of Harmonised Standards that can be used to demonstrate a Presumption of Conformance. This is the EU preferred route for manufacturers to follow. (The whole of the EU has been referenced when publishing these Harmonised Standards)

Harmonised Standards are authored by international organisations such as IEC (International Electrotechnical Commission), ISO (International Standards Organisation), ETSI (European Telecommunications Standards Institute) etc. These standards organisations have international representation on the committees and represent a worldwide interpretation of the issues of the day. (Many of these international standards have become the requirement in the North American market)

Once a standard has become a EU requirement, an “EN” (European Norm) signifies it is a European standard, and will have a publication date (important to note the publication date). The latest list of Harmonised Standards for any EU Directive/Regulation can be obtained from the internet. (but only from the official EU website). One method is to seach “EU Machinery Directive Harmonised Standards”, only select the website “ec.europa.eu” as the source, at the bottom of this website page is “summary list as pdf document”, this is the latest list.

The EN Standards are updated on a regular basis, it is very important to remain current, with the latest issues of the standards to ensure your compliance statement stays legitimate.

EU Standards are not the easiest to comprehend, every published standard has a list of Normative References (detailed in part 2 of the standard). Understanding any one applicable EN standard may require reference the one or more of the Normative References.

I would always advise the client to have the latest copy of the main EN standards in their library. This however is an expensive undertaking, especially if sourced in North America. The most affordable source of “EN” standards is;

www.evs.ee

This is the Estonia national standard website. EN Standards, are approx., a tenth of the cost compared with North America. Electronic copies can be downloaded immediately, once payment has been made via credit card in Euro. The website supports the English language. (You should select a multiple license, a couple of Euro more expensive, but will enable you to search the standard and save multiple copies).

A product that is in serial production, may be manufactured over many years. It is possible that the product must be re assessed as the directives, regulation and standards are updated. The applicable directive, regulations and standards are determined on the date the specific machine is first used on EU soil. The specific machine must meet all the latest issues of the directives/standards. There is not a “grandfather” clause in EU legislation. It is therefore very difficult to sell used machines into the EU, from outside the EU.

The second point to explain;
If you are a manufacturer that integrates several electrical/electronic products into the final assembly, it is vitally important you understand that meeting the CE Marking requirements is a multiple layered exercise. The components selected must be assessed against the appropriate component/sub system standard, for electrical safety AND Electromagnetic Compatibility (EMC), before you integrate the product. This is the only mitigating action the manufacturer can take to ensure the component/sub system is suitable for the intended environment.

Often manufacturers are prepared to take on the approval testing of the one component that has not been appropriately CE Marked. Of course, this can be undertaken, however it is expensive, and;

1. There is no guarantee the component will be compliant if it has not been designed to meet the requirements. This can lead to extensive re-test costs and modification.
2. The manufacturer does not control the production of the component, know of any changes in design or make up/content of the component. Therefore, the testing conducted would have to be repeated to ensure compliance on the next sample.
3. Compliance testing may include Electrical evaluation/test and EMC test as a minimum.
4. It is likely that the component can be sourced from another supplier, that includes all assessments, and be correctly CE Marked.

The third point to explain;
The manufacturer may be capable to conduct some of the Electrical tests in house, however it is unlikely that you have the EMC test equipment needed or the test facilities to conduct the testing. A typical test program (Electrical and EMC) for a component/sub system at a test facility will cost approx. $12,000.00 (2022 prices)