CE marking and the Technical File

Manufacturers who send equipment into the EU are required to send a CE compliant product in most cases. This means that if you are making an electromechanical device, chances are that you will need to comply with at least one, maybe a few, CE marking Directives. These could include the EMC Directive 2014/30/EU, the Machinery Directive 2006/42/EC, or the Low Voltage Directive 2014/35/EU.

These Directives (and the other CE marking Directives) allow the manufacturer to prove compliance on his or her own without the involvement of a regulatory authority (like OSHA through the NRTL program). The flipside of this, which is referred to as ‘self-certification’, is that you must retain proof that your product was in compliance when you placed it on the market in the EU. This ‘proof’ is compiled in the Technical File and you must be able to produce it for the authorities for ten years after you ship. This means that if you make an electric toothpick dispensing machine, and you sell many to the EU, you are required to be able to produce a Technical File for the authorities for ten years after you ship the last one to the EU.

The contents of the Technical File include the Technical Reports (test reports from an accredited laboratory) bill of materials, declarations of conformity or declarations of incorporation for equipment (and sub-assemblies) incorporated into your build, general layout drawings, schematics, and anything else required to prove that your equipment complies with the applicable CE marking Directives (EU laws) that you claim to comply with.

We are working with a customer who makes an electrical product and is selling this product into Europe. The distributor for this product sent our customer’s technical information (i.e., his Technical File) to a 3rd party lab for review of the compliance of the equipment to applicable CE marking Directives, in this case: the EMC Directive 2011/65/EU and the RoHS Directive 2011/65/EU.

The third party indicated that our customer did not comply with the Technical File requirements stated in the EMC Directive, specifically the requirements in Annex II (b) & (c):

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;

I assisted this customer by providing the below response. After I finished I thought that this could be useful information for other manufacturers. The name of the customer has been changed.

John,

The EMC Directive 2014/30/EU makes the requirement for a Technical File in Annex II (3.).

You asked directly about 2014/30/EU, Annex II (3.) (b):

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

…and 2014/30/EU, Annex II (3.) (c):

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;

First – keep in mind: this is a request made by a 3rd party lab (same as if someone asked me to audit your technical file).

This is not a request by market surveillance authorities: there is no legal weight to what they are asking.

In regards to what they are asking for my opinion is that all you are required to supply to satisfy Annex II (3) (b) & (c) in the technical file (you aren’t required to send this information to Europe unless a formal request is made) is the following:

  • General layout drawing
  • Electrical schematic
  • A key if the drawing is in another language
  • Operations and maintenance manual

Supplying that information will satisfy this requirement.

If you really get into this, you do not have to hand over the TF to anyone but the authorities and then only by request.

I have attached the EMC Directive 2014/30/EU.

Your obligations as the manufacturer are indicated in Article 7. See Article 7 (2), (3), and (9) regarding the TF.

Your importer or distributor can make a case to ask you for the TF. I suggest you defend against that.

The way to do it (in my opinion) is to reference this:

Importers – Article 9 (8)

  1. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of apparatus in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.

Distributors – Article 10 (5)

  1. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of the apparatus. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have made available on the market.

 Draft an agreement to hand over the TF to the authorities (or to the distributor or importer) only in a case where a written request by the authorities has been made.

Other than that, all you are required to supply is the product, declaration of conformity, and the manual(s)…. That’s it.

I hope this helps.

F2 Labs provides many CE marking services, including compilation of the Technical File so that instead of a large administrative headache at the end of your project you have everything organized on this:

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.

This entry was posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU and tagged , , , , , , , , , , , , . Bookmark the permalink.