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.

This entry was 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 and tagged , , , . Bookmark the permalink.

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