Fender Guitars and EU compliance, interesting read

In the interest of full disclosure, I own a Fender American Professional Telecaster, in butterscotch blonde of course, and a Fender Custom ’57 Champ Amp. I love Fender products. If it says “Fender” on it… I am usually considering the need to buy that product!

However, I found it very notable that the company has been fined in the UK for price fixing. This does not involve any sort of engineering compliance issue, but it does show the international reach of market surveillance authorities. These UK authorities determined that Fender employees intentionally did not write things down about this. Presumably (my assumption) is that these employees were concerned about subpoenas for emails.

The CMA (Competition for markets authority) uncovered this during the investigation. I find this worthy of posting to our blog because it is just as important – or maybe more important – to make sure your CE marking compliance issues are taken care of, correctly.

We are separated from the EU by an ocean but it is our continuing responsibility to ensure products placed on the market in the EU are compliant and safe.

We can be contacted via this link. We can be reached by phone at
877-405-1580 and are here to help you.

F2 Labs is here to help.

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Machinery Directive 2006/42/EC – The text and the harmonized EN standards

Complying with any EU CE marking Directive will require a trip to one of many European Commission websites that are set up to assist with the process. They are great sources of information, I have them bookmarked, and one or more are open on my computer usually during the day.

The Machinery Directive 2006/42/EC site is here: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/machinery/

Clicking that link will take you to a lot of good information. I have been asked a few times in the past two weeks about this so now is the time to lay it out in a (hopefully) useful F2 Tech Notes blog article.

The first thing you will see on that page is this chart:

There are two very important links in that chart. The innocuous label “OL No L 157, 9 June 2006” is a link to the Machinery Directive 2006/42/EC. Open that link and you will see the text of the Directive but also this:

English is my first language, so I scroll over to the “EN” and then click the pdf symbol below it. That opens a pdf version of the Machinery Directive in English, here. It opens as displayed below.

Are you new to CE marking and the Machinery Directive? I tell every F2 Labs customer the following, “Skip the recitals and go straight to Article 1. It’s all in plain English.” See below.

Next, go to Article 2 to see that everything in Article 1 has an easy-to-read definition.

The second very useful item in the chart from the top of this article is this:

I highly suggest clicking the link for the Guide to application of the Machinery Directive 2006/42/EC and saving it somewhere that is easy to get to. Because if you make machinery and you export to the EU you may learn that it is an invaluable tool that can be constantly referenced and learned from.

Next (and last) on the overall Machinery Directive page are the links to the Official Journal of the EU lists of harmonized EN standards. These are very important because only harmonized standards offer the presumption of conformity for your machinery.

Side note: What does this mean? It means that if you are complying with the Machinery Directive and you use the appropriate and applicable harmonized EN standards (harmonized means the standard is officially “linked” to the corresponding Directive) to evaluate and test – and it passes – then your equipment has the presumption of conformity. The authorities or anyone else looking at the equipment should assume it complies with the reference legislation when reviewing your EU declaration of conformity if you used harmonized EN standards.

Now, we turn our attention back to the Machinery Directive page we began this article with. Please, see three long links:

Those links are all important but they are all different. Choose wisely!

The first, for (EU) 2019/863, lists a number of standards that are withdrawn as harmonized standards for the Machinery Directive. The associated dates next to each standard tell you when you can no longer indicate these standards on your declaration of conformity if they are applicable to your equipment. You will have to find a different set of standards to test/evaluate. This Commission Implementing Decision was published this month (November 2019) to address some ambiguities and mistakes made in the second link ((EU) 2019/436). One notable mistake is that (EU) 2019/436 calls for the withdrawal of EN ISO 12100:2010. We wrote about that, here, because it was a major development.

Another correction to (EU) 2019/436 is that it lists standards to be withdrawn but does not indicate the date at which they (the indicated, withdrawn standards) no longer confer a presumption of conformity (i.e., the date you can no longer use them to prove compliance to the Machinery Directive).

The second, for (EU) 2019/436, lists the following:

  • Annex I – applicable new or amended harmonized EN standards
  • Annex II – harmonized EN standards that now have restrictions
  • Annex III harmonized EN standards to be withdrawn (but no date for withdrawal, see (EU) 2019/863)

Finally, we arrive at the current “list” of harmonized EN standards for the Machinery Directive in the last link:

That link takes you to the current list that is published in the Official Journal of the EU, or “OJ” as it is often referred.

At this time, for any new projects, we suggest that (EU) all three links must be consulted if you are determining which EN standards are applicable to your equipment. Or, contact us at F2 Labs. We can help sort it out.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

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EN 60950-1 and EN 62368-1

We are starting to feel some more effects from the upcoming replacement of EN 60950-1 by EN 62368-1. This is causing some confusion in the compliance world as well and I wanted to share a recent example that we were contacted about.

The customer builds equipment that is a combination of three subassemblies that are themselves independently operational. These devices, when combined, create a new device which itself must carry a CE marking (remember, “CE + CE does not always = CE”).

This customer engaged F2 Labs after working with another lab and even had me come to his facility for a two-day training seminar this past summer.

He contacted me because the other lab refused to accept that one of the assemblies was tested to EN 60950-1. The lab indicated that the assembly must be tested to EN 62368-1 to be acceptable because EN 60950-1 is expired.

Upon reading the email from our customer I next opened the link to the Official Journal of the EU’s list of harmonized EN standards for the Low Voltage Directive 2014/35/EU, here. Next, I searched for EN 60950-1 and it appeared in the chart next to EN 62368-1. See below.

What does this mean? I have written about this topic, previously, here. There is another article on our blog that goes into this topic in much greater detail, here. EN 60950-1 is formally expiring on December 20, 2020 and at that time you will no longer be able to send equipment to Europe under EN 60950-1. You will need to submit the equipment for testing to EN 62368-1 so that you have a technical report, from an A2LA accredited lab, in your Technical File.

It’s also helpful to read the “Note 2.1” that is in the bottom of the grid square that lists EN 60950-1. See below.

So, our advice is that if you have a product to send now and it was tested to the current version of EN 60950-1 then you can do it. However, expect to be questioned about it (by your EU customer or maybe even in customs) and it is probably a good idea to schedule testing to EN 62368-1, soon. We expect a lot of last minute EN 62368-1 projects in Q3 and Q4 of 2020.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

Don’t stress about any of this… call F2 Labs!

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RoHS 3 – (EU) 2015/863 – Some FAQ’s

Now that we have been under the ‘new’ EU RoHS for a few months I thought it would be a good time to write a brief article to cover some of the most commonly asked questions.

  • What changed? RoHS 2011/65/EU restricts six substances. (EU) 2015/863 adds four more substances to this list. The original six substances are four heavy metals (including lead, not just lead) and two flame retardants. (EU) 2015/863 is an amendment to 2011/65/EU which added restrictions on the use of four phthalates.
  • What are phthalates? Phthalates are also called ‘plasticizers’ These are chemicals used in plastics to make them more flexible.
  • Does everything have to be retested to prove compliance? Not necessarily. Parts that are made of metal, 100%, have no phthalates. Most manufacturers have known about this amendment since it was introduced, four years ago, so chances are your products need new documentation but not new testing.
  • Since (EU)2015/863 is an amendment to the RoHS Directive 2011/65/EU then isn’t a claim of compliance to RoHS 2011/65/EU also a claim of compliance to (EU)2015/863? That can be a question that is subjective, based on a few other “ifs”. For example, if the document claims compliance to RoHS 2011/65/EU and lists only the original six substances then we would not accept this (F2 Labs performs many EN 50581:2012 reviews for our customers). However, if the document indicates compliance to RoHS 2011/65/EU, while not indicating the list of restricted substances, and it is signed & dated past July 22, 2019 – we would probably accept it.

There are a few nuances to RoHS and we can help you with this.

We can be contacted via this link. We can be reached by phone at
877-405-1580 and are here to help you.

F2 Labs is here to help.

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Translations and CE marking

This is an often-asked question, “Do I need to translate the manual for the EU and what do I need to translate?”

The answer is everything that is needed top assemble, safely operate, maintain, and eventually dispose of the equipment must be translated.

The EU changed the requirements for translations with the 2008 New Legislative Framework  (also called the 2008 NLF or just NLF). Several new CE marking Directives resulted from this including the below, though not an exhaustive list:

With these new Directives came more precise definitions of some terms and an alignment of requirements between the Directives. Prior to the 2008 NLF it was common to see differing requirements for the same document from Directive to Directive. For example, the formats for the declarations of conformity differed from one Directive to the next. The EU attempted to change that with the NLF and in addition to streamlining, they also tightened-up definitions, including the definitions and responsibilities of three classes of economic operators:

  • Manufacturers
  • Importers
  • Distributors

This article focuses only on the translation requirements as concerns manufacturers. In plain English: if you are a manufacturer in the United States and you want to send a product to the EU then you will need to translate everything associated with it into the native language of every country you send it to.

Oftentimes I will break this down and document it for a customer who asks. Today I was asked again and decided to lift that information from the email and place it in a blog article here for future reference. In this case the customer has a product that is in the scope of the Radio Equipment Directive 2014/53/EU and asked how much material (instruction and operation manuals, maintenance manuals, quick start guides, etc.) needs to be translated.

Below is the response. Documented in the response is the requirement in the Radio Equipment Directive 2014/53/EU, the explanation of Article 10 (8) in the RED guide, and section 3.1.4. from EU Blue Guide to Product Rules, which is referenced in section 2.6 (j) from the RED guide.

See the RED 2014/53/EU, Article 10 (8.)  –

Article 10

Obligations of manufacturers

8. Manufacturers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Instructions shall include the information required to use radio equipment in accordance with its intended use. Such information shall include, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. The following information shall also be included in the case of radio equipment intentionally emitting radio waves:

(a) frequency band(s) in which the radio equipment operates;

(b) maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates.

Next see the RED guide (attached), section 2.6 (j) –

j) Instructions

Article 10.8 of the RED requires manufacturers to accompany the equipment by instructions and safety information in a language which could be easily understood by consumers and other end- users, as determined by the Member State concerned. Furthermore, they shall be clear, understandable and intelligible. The Blue Guide, in Chapter 3.1.4, provides more details on how the instructions and safety information need to be provided. These instructions shall also include information required to use the radio equipment in accordance with its intended use. In particular, this information shall include, where applicable, a description of accessories and components, including software:

(1) have an influence on the conformity of the radio equipment, and

(2) are intended to be installed or changed by the user without the control of the manufacturer.

Accessories example:

? If the radio equipment is delivered without an antenna, then the technical features of the antenna that may be used in conjunction with the radio equipment shall be provided to the user. The user is responsible to operate the radio equipment and the accessories as intended and according to the description provided by the manufacturer. These technical features of the accessories shall therefore be mentioned in the instruction manual in order to enable the user to operate the compliant radio equipment. This information could be the generic characteristics of a given antenna type or a reference to a specific antenna(s) available on the market.

Software example:

? If the radio equipment has software (such as firmware, PC controlling software) that can affect its compliance with the Directive and the manufacturer intends and offers the possibility to the user to freely change it or modify it, then the software should be named in the instruction manual so that it is possible for the user to put a compliant radio equipment into operation. The manufacturer can decide the format of the description of this software as long as it can be identified.

On the other hand, if the radio equipment has software that can affect its compliance with the Directive but the manufacturer does not intend to allow the possibility for the user to change it or modify it, then no information has to be provided in the instruction manual. This is often the case of “software updates over the air” where the new software is installed under the full control of the manufacturer with no access by the user. In these cases the manufacturer ensures the installation of new software for which compliance with the Directive has been already assessed and reflected in the Technical Documentation.

With the objective of supporting authorities on their market surveillance activities, Article 10.8 of the RED requires manufacturers to accompany radio equipment which intentionally emits radio waves with information on the frequency bands and maximum output power with which the equipment is able to operate in the EU.

Manufacturers have different alternatives to fulfil these requirements. For example, any of the following options could be added to the instructions:

? the nominal frequency and transmitted power (radiated and/or conducted) used by the radio equipment, as reflected in the Technical Documentation,


? for radio equipment using standardized technologies, e.g. GSM/3G/LTE, indication of the frequency band in the way they are commonly well known (such as GSM 900, 1800). Where different power levels are possible, the nominal maximum power would be stated.

Next see section 3.1.4 from the Blue Guide:

As a general rule, when placing a product on the market the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products and in particular:

4.accompany the product with instructions and safety information as required by the applicable Union harmonisation legislation, in a language easily understood by consumers and other end-users, as determined by the Member State concerned. Unless otherwise specified in specific legislation, instructions and safety information need to be provided, whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by non- professionals, the design and instructions accompanied must take this possibility into account;

Our guidance and advice, based on the above and other similar documentation for other CE marking Directives, is that the manufacturer must make a translation of everything.

We can be contacted via this link. We can be reached by phone at
877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU | Tagged , | Leave a comment

CE marking FAQ

Frequently at F2 Labs we get very deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking required.

There is no reason to feel any apprehension. We help customers to comply with CE marking requirements every day. We also help customers understand that some requirements foisted upon the project by a buyer are not even legally required.

Below is a list of some very common questions asked all the time by our customers who are new to CE marking. This list was drafted to send out to our customers at the start of a project. I thought it could be useful as an article for our blog. We hope this is helpful, please see below.

CE marking Overview – Frequently Asked Questions


  • Placing a CE marking on your equipment means that you are making a claim that your product complies with any EU CE Directive that applies to your equipment.
  • The manufacturer places the CE marking, it is not issued by a testing laboratory.
  • Self-certification means that you, as the manufacturer, can place the CE marking without having a test lab place the marking (as is case with North American safety compliance, i.e., “Listings”). In most cases this will require technical intervention by an accredited 3rd party laboratory, like F2 Labs.
  • Your product must be accompanied by an EU Declaration of Conformity, or in some cases, a Declaration of Incorporation for Partly Completed Machinery.
  • In all cases you are required to compile and maintain a Technical File at your facility for ten years after you ship the last product to the EU.
  • The Technical File must contain the proof that your equipment complies with the applicable Directives. In almost all cases that will require Technical Reports prepared by an accredited 3rd party lab.
  • Only the authorities in the EU have a right to see your Technical File. You are not obligated to deliver the technical file to your customer as a part of CE marking compliance.

The Directives:

  • The Machinery Directive (MD) 2006/42/EC, is applicable to machinery, broadly defined as anything with linked components that move under other-than-human power. Some lifting apparatus and attachments for machinery are also included as is lifting devices that rely on human power.
  • The EMC Directive 2014/30/EU is applicable to anything with active electronics.
  • The Medical Device Directive (MDD) 93/42/EEC is applicable to medical devices.
  • The Low Voltage Directive (LVD) 2014/35/EU is applicable to any product with an input voltage of 50 – 1,000 VAC or 75 – 1,500 DC.
  • The Radio Equipment Directive (RED) 2014/53/EU is applicable to all equipment with any wireless function. It also makes the technical requirements of the LVD automatically applicable, regardless of voltage.
  • The Pressure Equipment Directive (PED) 2014/68/EU is applicable to any product with a pressure of .5 bar and above but there are numerous exclusions.
  • The ATEX Directive 2014/34/EU is applicable to equipment that operates in a potentially explosive atmosphere. However, explosive risks generated in your machinery are covered by the Machinery Directive 2006/42/EC.
  • The Restriction of Hazardous Substances Directive (RoHS) 2011/65/EU is applicable to any device with any electric power or function. This means even a device with a piezo ignitor button.

F2 Labs is here to help.

Please call us at 877-405-1580.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Leave a comment

Sending equipment to the EU when compliance is not an obvious path

Manufacturers contact F2 Labs from around the world to ask for assistance with EU regulations. While F2 Labs primarily focuses on electro-mechanical devices, including medical devices, we have also assisted many people with an understanding of what is legally required.

An example of this could be a manufacturer of an aircraft sub-assembly that has an installed laser as a part of the sub-assembly. The device itself is used in a military / security application and is powered from the aircraft battery. The question to F2 Labs in this case is usually, “what is applicable?” Since in our experience the end-user in the EU oftentimes is not able to provide this information to the manufacturer (and it’s not their responsibility either), we try to help.

In this case the device is DC powered and is below the voltage levels of the LVD 2014/35/EU scope. The LVD is applicable as per Article 1, paragraph 2:

Next, we look at Annex II and see this:

Note that although the equipment can be excluded from the scope of the LVD it must be in the scope of some other safety requirement in order to really be “out of scope”. However, this equipment is excluded even before we get to Annex II… because it operates from an input voltage lower than the scope of the LVD (per Article 1, paragraph 2).

In other words: if it is technically in the scope of the LVD and is also aeronautical equipment it can only be excluded from the LVD if it falls under the aeronautical regulation. You cannot exclude your equipment from the LVD because it’s aeronautical and then also exclude it from the aeronautical regulation.

Now we look at the EMC Directive 2014/30/EU. See Article 2, Scope 1:

Next, see Article 2, (2.), (b):

OK, here is a wrinkle. The EMCD 2014/30/EU is not applicable to aeronautical products if they are in the scope of Regulation (EC) No. 216/2008. Immediately we see Article 2 (2.) in Regulation No. (EC) 216/2008:

So, it is excluded from this regulation because it has a military / security application. This means therefore it is not excluded from the EMCD 2014/30/EU (because only aeronautical equipment in the scope of Regulation No (EC) 216/2008 is excluded from the EMCD 2014/30/EU).

We advise compliance with the EMC Directive 2014/30/EU using whatever applicable harmonized EMC testing standards are relevant.

Interesting to note that the Low Voltage Directive 2014/35/EU is nuanced because although the subject equipment could not escape the Low Voltage Directive 2014/35/EU due to being in the scope of Regulation No (EC) 216/2008, it is still out of scope due to being below the minimum voltage limit.

And there is a laser. Overall assemblies are in the scope of the harmonized Low Voltage Directive standard for laser safety, EN 60825-1:

But this is not in the scope of the Low Voltage Directive, so now what?

Our advice is this:

  1. Comply with the EMC Directive 2014/30/EU
  2. Have the apparatus tested to an appropriate safety testing standard, probably EN 62368-1, and receive a compliant report.
  3. Have the apparatus testing to IEC/EN 60825-1 and receive a compliant report.
  4. Indicate that the equipment is compliant to the EMC Directive 2014/30/EU on the EU declaration of conformity and additionally indicate that it has been tested to appropriate European safety standards, including laser testing, by listing those standards and report numbers on the document, but do not claim compliance to the Low Voltage Directive 2014/30/EU.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC | Tagged , , , | Leave a comment

Ronin Revolution Corporation earns EC type-examination Certification for Ronin Lift from Notified Body.

Ronin Revolution Corporation worked with F2 Labs to evaluate and test the
Ronin Lift for compliance with the relevant CE marking Directives required to sell their product in Europe. The Ronin Lift is a personal ascender used to lift people for both recreation and tasks.

We advised the engineering staff at Ronin that the equipment, a lifting device for people, is in the scope of the equipment listed in Annex IV of the Machinery Directive 2006/42/EC. Particularly, Annex IV (17), see below.

Equipment that is indicated in Annex IV is the only category of machinery that requires Notified Body involvement, in the form of an EC type-examination certificate. This is required under the following conditions:

  1. The equipment is listed in Annex IV.
  2. All the risks are not addressed by harmonized standards.

See Article 12 (4.) (a) below:

The engineering staff at both F2 Labs and Ronin Revolution Corporation worked together, extensively, to resolve the detailed risk assessment generated for the Ronin Lift and then set about testing every facet of the equipment. No stone was left unturned in preparation of the EC-type Examination. F2 Labs next assembled a complete Technical File, per 2006/42/EC, Annex VII (A.) and made contact with a Notified Body in the EU to finish the process.

After many rounds of testing, evaluation, and numerous conference calls, we are pleased to announce that Ronin Revolution Corporation has earned the EC type-examination certificate for the Ronin Lift. Congratulations from your friends and colleagues at F2 Labs!

F2 Labs is here to help.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

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CE marking – Equipment is stopped in French customs, what now?

The sales department at F2 Labs fields phone calls from primarily US manufacturers. We have heard every scenario imaginable as pertains CE marking, from, “What is CE marking? We are about to disassemble and crate our machine and noticed that CE is required in the purchase agreement,” to, “We have been shipping to Europe for twenty years without a CE marking and have never had a problem.

Getting your product through customs can seem like a roll of the dice but it is really not that complicated. Here is what you need:

  1. CE compliant product with a CE marking.
  2. EU declaration of conformity in the language of whatever country you are sending the equipment to.
  3. A Technical File at your facility, prepared and stored securely, and ready to deliver to the authorities if your product is stopped.

Note that for item 3 above you must be able to hand over a Technical File to the authorities if asked. Never send it with the product or to your customer. The Technical File is your proprietary information about your device and is your proof that it is compliant and was in a compliant state when sent to the EU. No one has a right to view it outside of your company except the authorities. And if they want it, they will ask for it.

Let’s look at a hypothetical case.  One of our customers has a stopped shipment in French customs. The product is a machine and was a model in a series of very similar models in a product family. A series approach to compliance is very routine, particularly with electro-mechanical devices. In most cases we advise that if there is a series of nearly identical equipment then the appropriate route is to test the most complex and “worst-case” configuration, the customer can then use the resulting Technical Reports to justify the compliance of the other models in the series.

The customs authority will next make a request for the Technical File and may indicate, upon review, that our customer’s product cannot proceed because the model that we tested (and indicated in the resulting IEC/EN Technical Reports in the Technical File) is not the same model as the model indicated on the declaration of conformity for the unit that is stopped in customs.

In most cases our customer will contact us at this point and ask for assistance. That is advisable. We can and will help you. We will next make a review of the correspondence between our customer, the international shipper, and the customs official. This will result in the following guidance, almost always:

Machinery Directive 2006/42/EC, Article 12 –

Article 12

Procedures for assessing the conformity of machinery

  1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.

  2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.

In almost all cases, the manufacturer will follow Article 12 (1), (2), & (3) (a).

Please see Annex VIII, as referenced in Article 12 (3) (a) and note in particular, Annex VIII (2).


Assessment of conformity with internal checks on the manufacture of machinery

  1. This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.

  2. For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.

  3. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.

We also note the guidance and direction regarding this as presented in the Guide to Application of the Machinery Directive 2006/42/EC, Edition 2.1.

See section 395, para 2:

Section 2 of Annex VIII recalls the obligation of the manufacturer or his authorised representative to draw up a technical file according to Annex VII A 1 for each type of machinery – see §103: comments on Article 5 (1) (b). The technical file must identify the EHSRs applicable to the machinery and describe how they have been fulfilled. The term ‘representative type’ is equivalent to the terms ‘type’ or model – see §392: comments on Annex VII A 1.

Next, see the referenced section 392, para 3 pertaining to ‘representative type’ from the guide –

A technical file is required for each model or type of machinery. The terms ‘model’ or ‘type’ designate machinery with a given design, technical characteristics and application. A type of machinery may be produced in series or as a single unit. One type of machinery may have variants; however, to be considered as belonging to the same type, variants must have the same basic design, present similar hazards and require similar protective measures. The description of the machinery in the technical file must specify any variants of the model or type concerned.

The subject equipment referenced on the declaration of conformity is extremely similar in design, function, and use as the model that was evaluated and tested in our laboratory.

The guidance provided by the European Commission in the Guide to application of the Machinery Directive 2006/42/EC, and displayed above, is the methodology we use when advising US manufacturers in regards to this common situation.

I hope this helps.

The stopped shipment has been immediately released in every case that the above synopsis of the Machinery Directive requirements concerning series manufacture and compliance has been referenced to EU customs officials.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

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Building a machine for the EU? Here is some wiring guidance from one of our senior safety engineers.

We help manufacturers every day with the task of CE marking their equipment for shipment to the EU. Very often we are asked questions by our customer’s engineering staff and one of the most common questions pertains to wire colors. The main electrical safety standard for machinery is EN 60204-1 – Electrical equipment of machines – Part 1: General requirements. EN 60204-1 is a B-type Machinery Directive standard and tells machine makers what colors are required for different wires, in clause 13.

However, it can be difficult to interpret, sometimes, exactly what the authors of the standard mean. If you are questioning what it means… it’s not you, it’s the standard. We get asked all the time about this subject.

Yesterday one of our senior safety engineers provided a response to this question for me to forward to a customer. The email he wrote is below for future reference.

F2 Labs is here to help.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in CE marking | Leave a comment