CE Marking

srnet

Senior Member
I have been trying to get a definitive answer as to whether you can apply ‘self-certification’ to an electronic product that includes a transmitter.

You may have seen my various posts on the LoRa transmitters, and there is potential for a marketable product there.

However it’s not clear if CE marking for such a product, a 10mW transmitter operating in the 434 MHz ISM band, would require compulsory approved body testing, which would likely be expensive.

Does anyone have a definitive answer or have a contact in a notified body that would know for sure what the position is?
 

srnet

Senior Member
You will need to obtain CE Certification: https://www.gov.uk/european-commission-product-directives#electromagnetic-compatibility
All products sold must comply with e.g. EMC regulations there is much else to comply with too such as WEEE. The government web page explains all.
Hardly explains all.

You dont 'obtain' CE certification as such, its something you can apply yourself, in some circumstances. Its the precise details of when you can and cannot apply the certification yourself (self certification) that is the tricky point. It hinges on whether the product is covered by a 'harmonized standard' and the precise detail of that is not clear.
 
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eggdweather

Senior Member
I found these key extracts:
All apparatus placed on the market from 20 July 2009 must have a declaration of conformity to EMC Directive 2004/108/EC.
And:
There are a number of requirements that must be fulfilled before apparatus within the scope of the Regulations can be placed on the market:
• the apparatus must be compliant with the essential requirements
• compliance must be demonstrated by a documented conformity assessment process
• technical documentation must be prepared and available to the enforcement authority on request
• a declaration of conformity must be drawn up
• the CE marking must be applied
• manufacture of the apparatus must take place in accordance with the technical documentation drawn up by the manufacturer
• each individual apparatus placed on the market must be accompanied by the appropriate information to ensure that when put into service, the apparatus complies with the essential requirements
Attention is drawn to the need for conformity to be demonstrated, and documented in the technical documentation, and for appropriate information to be supplied with each apparatus.
Before setting out to comply with the Regulations, the manufacturer should check whether their apparatus is covered by them. Some information on excluded apparatus is provided in Annex 2 of this guide.
If the apparatus is covered by the Regulations, and is intended for supply only to a given fixed installation, and it is not otherwise commercially available, the manufacturer has the option of using the exemption from conformity assessment as described in 4.4 of this guide (since apparatus covered by 4.4 of this guide need not meet the essential requirements for emission and immunity in isolation from the fixed installation).
And:
There is a flow chart that takes you through the assessment requirement process.
 

srnet

Senior Member
I found these key extracts:
All apparatus placed on the market from 20 July 2009 must have a declaration of conformity to EMC Directive 2004/108/EC.
And:
And must conform to all other directives and harmonized standards that apply ................

Which directives apart from the EMC one would apply to a battery powered transmitter ?

Which are the appropriate harmonized standards that would apply to a battery powered transmitter ?
 
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eggdweather

Senior Member
Well I was focussing on the EMC directive/regulation and this statement:
The regulations require that all electrical and electronic apparatus marketed in the UK, including imports, satisfy the requirements of the EMC Directive. The regulations implement a separate regime for fixed installations.

Because you have an RF transmitter and so the EMC must apply. If your module was CE approved, then my guess is you would not require to undertake an assessment, it's a bit like the external PSU path many suppliers chose when they had to prove electrical safety, they just passed the responsibility to the PSU manufacturer.

Battery power or PSU powered, the regulations are the same, basically is the 10mW going to interfere with any other user of the RF bands, is it on frequency and is the transmitted harmonic content below the regulatory requirement. All this (of course) only comes into effect when selling/marketing a product, for home use, whilst the regulations still applies, Ofcom would probably not enforce regulations unless it could be proved the equipment caused interference. Ofcom do regularly prosecute individuals in the amateur radio world, so it is a real world problem to consider and similarly when a device interferes with a Amateur band (433Mhz either on a primary or secondary use basis) they will act to find the source and take measures to control it, again a well published and frequent event.

Your device is well within: http://stakeholders.ofcom.org.uk/spectrum/information/licence-exempt-radio-use/licence-exempt-devices/short-range-devices-information
SO there is no licence requirement, but type assessment with evidence does unfortunately still appear to be a requirement. For self-assessment purposes, my view is providing you have evidence of design and of your RF module and all associated design documentation and data sheets, then that should be adequate evidence to hold for assurance purposes.

Plus:
The following principles shall be carried out when CE Marking take place by Self Certification:
•The manufacturer, his authorised representative or the importer (economic operator) must ensure and declare that the products meet the essential requirements of applicable directives;
•The economic operator shall establish the technical documentation (Technical File) and keep it for at least ten years after the last product is available for inspection by the competent national authorities
•Based on the TF, the economic operator must be able to demonstrate whether the product complies with the essential requirements of the applicable directive (s). When applicable, the Technical File also covers the design, manufacture and operation of the product
•The economic operator shall take all necessary measures, to ensure that the products are manufactured in accordance with manufacturing process as drawn up in the Technical File and with the essential requirements of the Directive (s) related to the product.

On balance I think self-assessment is viable.
 

hippy

Technical Support
Staff member
Self-certification is entirely possible and I would expect most CE marked products are self-certified. Unless the entire process is handed to a sub-contractor then the manufacturer will have to self-certify.

Certification is simply a legal statement that the product complies with all applicable regulations. The certifier can say 'yes it does' but that must be based on evidence that it does.

That evidence may be implicit ( relying on certification of component parts etc ), demonstrated by in-house or by outside testing. Unless a regulation explicitly demands approved body testing that would be optional.

It is not so much about certifying as about getting the evidence such certification is based upon.

The questions here then are (1) whether any applicable regulation requires approved body testing and, (2) whether the implicit evidence and in-house testing evidence is good enough to avoid outside testing.

For (1) I would say probably not but it would depend on exact final product details, and for (2) I could not even guess because I don't know what evidence there is.

I would say it all comes down to how confident one is that a product does comply and, more importantly, how good the evidence is that it does comply, should anyone commence legal action saying it does not.

Outside testing ( approved body or otherwise ) will probably be required where the implicit evidence and in-house testing is not good enough to be supporting evidence for saying it does comply. Outside testing may also be chosen because they are more able to do testing and assessment than in-house.

Certifying is legally asserting 'it complies' with the risk of punishment if that is not so. How the evidence that backed that certification is seen by the court is what really counts; did it justify that assertion made ?

What one can do, what one should do, and what it is best to do, can all be valid but different things, and experts in the field are best placed to advise.

As well as OfCom there is also the government's Department for Business, Innovation & Skills (BIS), and there may be local Business Initiative groups who might be able to help.
 
And must conform to all other directives and harmonized standards that apply ................

Which directives apart from the EMC one would apply to a battery powered transmitter ?

Which are the appropriate harmonized standards that would apply to a battery powered transmitter ?

Most likely the R&TTE Directive which covers radio transmitters - I believe this has been revised and new equipment must comply with the new Directive from some time next year with a further period of a year for equipment certified to the previous Directive.

Being battery powered, your equipment would be exempt from the Low Voltage Directive.

The equipment would have to comply with the Restriction of Hazardous Substances Directive.

The WEEE Directive isn't part of CE marking (or at least it wasn't when I was involved with product certification) because it concerns the recycling of equipment at the end of life.

A listing of the applicable harmonized standards is usually published in the Official Journal of the European Communities.

Mostly I used TUV Product Services at Fareham and I am sure they can advise on the certification requirements and harmonized standards. The following link may help:

http://www.tuv-sud.co.uk/uk-en/resource-centre/legislation-downloads

I assume you are using a bought in transmitter module - is it CE marked? If it is (and you have confidence that it is genuine - ask for a Declaration of Conformity), then perhaps the Technical File approach may be possible.

Richard
 

inglewoodpete

Senior Member
I'm sure there must be a difference between "placed on the market in the EU" and "operated in the EU" in relation to radio transmission equipment. This discrimination seems to be largely missing from the arguments above.
 
I'm sure there must be a difference between "placed on the market in the EU" and "operated in the EU" in relation to radio transmission equipment. This discrimination seems to be largely missing from the arguments above.
The original posting of this thread was about this device being turned into a product for sale within the EU. From the European Commission "Blue Guide":

• A product is placed on the market when it is made available for the first time on the Union market.

• Products made available on the market must comply with the applicable Union harmonisation legislation at the
moment of placing on the market.

Not only is the manufacturer (or importer into the EU if the item is manufactured outside the EU) responsible for ensuring compliance with the CE marking requirements, but all others in the distribution chain are as well. The end customer doesn't have any responsibility for ensuring oompliance, so you are correct in that there is a difference between "placing on the market" and "operating in the EU".

If the product is compliant in one EU member country, then it may be sold in all the other 24 (or however many it is these days) member countries.

The Technical File approach may be permissible and this file must contain the evidence as to why the manufacturer claims that the product is compliant.

EU Directives are a mine field. Fortunately, I'm now retired and no longer have to worry about them!

Richard
 

srnet

Senior Member
Mostly I used TUV Product Services at Fareham and I am sure they can advise on the certification requirements and harmonized standards. The following link may help:

http://www.tuv-sud.co.uk/uk-en/resource-centre/legislation-downloads
Thanks I will contact them, see what they say.

I dont have a problem with the process for self certification in itself, but you can only go down that route if your confident what your building and selling complies with all appropriate directives and applicable harmonized standards. Thats when it gets decideadly tricky, especially as you dont seem to be able to view the detail of the standards without buying them. Bit of a waste of money to buy a standard and find it does not apply.

The module itself is not CE marked.

And agreed with your later comment "EU Directives are a mine field".

One thing I did come across, is that 'kits' must also be CE marked on the basis that they are completed products, I had thought they were excempt.
 
I agree about the cost of Standards. You buy a Standard only to find it calls up another Standard that you then have to buy and so ad infinitum, or so it seems.

I wasn't aware that kits were also covered. My only dealings with kits has been for Amateur Radio projects and these are specifically exempted from the requirements of the R&TTE Directive.
 

hippy

Technical Support
Staff member
One thing I did come across, is that 'kits' must also be CE marked on the basis that they are completed products, I had thought they were excempt.
That makes sense. The CE principle is that anything put on the market must be compliant no matter who does final assembly. It is really certifying the item will be compliant once assembled as per instructions. It prevents non-compliant product being put on the market, or compliance regulation to be circumvented, by supplying as a kit.

There are however cases where CE marking is not required for kits; where compliance is not of itself necessary or is exempted in the assembled item, such as when it's a kit to make a sub-component. So it comes down to what type of kit it is.
 

srnet

Senior Member
There are however cases where CE marking is not required for kits; where compliance is not of itself necessary or is exempted in the assembled item, such as when it's a kit to make a sub-component. So it comes down to what type of kit it is.
Yes, my example is a working stand alone finished product; a GPS tracker.



This would appear to require CE marking, but the RFM98 radio module or GPS I use does not.
 
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