{"id":456,"date":"2017-04-07T13:50:51","date_gmt":"2017-04-07T17:50:51","guid":{"rendered":"https:\/\/f2labs.com\/technotes\/?p=456"},"modified":"2019-05-08T11:51:01","modified_gmt":"2019-05-08T15:51:01","slug":"ce-marking-and-the-technical-file","status":"publish","type":"post","link":"https:\/\/f2labs.com\/technotes\/2017\/04\/07\/ce-marking-and-the-technical-file\/","title":{"rendered":"CE marking and the Technical File"},"content":{"rendered":"

\"\"Manufacturers who send equipment into the EU are required to send a CE compliant product <\/a>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<\/a>, the Machinery Directive 2006\/42\/EC<\/a>, or the Low Voltage Directive 2014\/35\/EU<\/a>.<\/p>\n

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<\/a>). The flipside of this, which is referred to as \u2018self-certification\u2019, is that you must retain proof that your product was in compliance when you placed it on the market in the EU. This \u2018proof\u2019 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.<\/p>\n

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.<\/p>\n

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\u2019s technical information (i.e., his Technical File) to a 3rd<\/sup> 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<\/a>.<\/p>\n

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):<\/p>\n

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;<\/em><\/p>\n

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;<\/em><\/p>\n

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.<\/p>\n

John,<\/strong><\/em><\/p>\n

The EMC Directive 2014\/30\/EU makes the requirement for a Technical File in Annex II (3.).<\/strong><\/em><\/p>\n

You asked directly about 2014\/30\/EU, Annex II (3.) (b):<\/strong><\/em><\/p>\n

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;<\/strong><\/em><\/p>\n

\u2026and 2014\/30\/EU, Annex II (3.) (c):<\/strong><\/em><\/p>\n

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;<\/strong><\/em><\/p>\n

First \u2013 keep in mind: this is a request made by a 3rd<\/sup> party lab (same as if someone asked me to audit your technical file).<\/strong><\/em><\/p>\n

This is not a request by market surveillance authorities: there is no legal weight to what they are asking.<\/strong><\/em><\/p>\n

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\u00a0(you aren\u2019t required to send this information to Europe unless a formal request is made) is the following:<\/strong><\/em><\/p>\n