"CE" mark self certification


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  1. #1
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    Default "CE" mark self certification

    Hi, I have a problem and I am getting no assistance from the EU, their Market Surveillance folks - nobody. Hopefully one of you folks can assist me.

    My company manufactures test equipment that is directed by the Boeing Aircraft Company in their aircraft manuals to be used on the aircraft to test/verify components of the jet engine. The LVD annex II says that "Specialized Electronic Equipment" used on the aircraft is exempted from the LVD standard and therefore would not need the "CE" mark. However, we have a customer that is making noise about our equipment requiring the "CE" approval. He says that equipment being used "ON" the aircraft means that it flies with the aircraft. Our equipment is used on the ground, on the aircraft to test and verify.

    If we decide to self certify our equipment (which I beleive it will pass) what standard(s) should we use? Is there a general standard that is easy to pass? Or is there some special standard we must use because we sell test equipment used on aircraft? Anyone have any ideas??

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    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.

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    Quote Originally Posted by Melanie
    if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.
    Hi Melanie,

    Do you have any links to sites that explain those directives in plain english that a normal person can understand without a degree in legalease.

    I tried to find simple explanations but couldnt find any and as far as I could see you need to spend serious money to get an official copy of any directive which would then take you the rest of your life to read (based on the fact that you would lose the will to live!)

    I did buy a book that was recommended to me but still cant figure out what you *should* do
    Keith

    www.diyha.co.uk
    www.kat5.tv

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    Quote Originally Posted by Melanie
    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.

    NO, Here Malanie is bending the rules.

    Yes "If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so"

    BUT you are required to test to standards that are relevant to the use of the product, so you can't do as Melanie suggested AND stay legal.

  5. #5
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    Default The part that hurts the most

    When Melanie said:
    Quote Originally Posted by Melanie
    I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf.
    This in itself wouldn't "officially" be enough. How can you say something meets the standard if you don't have an actual copy of the standard?

    Even Lester says "just read the legislation, it's not difficult".

    Here is the problem with the whole system. They "SELL" the standards. They aren't free to download for review. It really makes it hard on the small entrepreneur to get a product into Europe. Some of them aren't cheap either. I'm in the laser safety business and IEC 60825 alone has 15 parts which cost ~$65 each. On top of that I need the machinery directive, the low voltage directive, the EMC directive, and most likely something else I've never thought of.

    I guess paying for a testing house to tell you that your product meets the standards is worth the $6k to $12k.

    In the end, I think Europe loses out on some innovative products because people are afraid to introduce something new. At the very least, movement of products into Europe is delayed because of the added bureaucracy.

    They say it will take something like 20 years to get back to where we can put a man on the moon. It's hard to believe we once did it in 8. It all boils down to bureauracy.

    John

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    John I ahve to agree with your sentiments. Right now the bureaucracy in the EC is at a crzy level and does not look like its going to ease.

    Yes its sensible to have harmonisation of standards, but when it's implimented as it is right now, it is simply restrictive.

    Maybe thats why we have so many poeple working in software and so few in hardware and firmware.

    AND, with so much legislation that is both costly and difficult to identify, its easy to see why we end up with "the blind leading the blind" which ultimately defeats the very purpose of the legislation.

    However it works both ways, I find it really difficult to find a route to FCC Type approval that does not cost over 3 times as much as EMC testing and CE marking!

    Incidentally, there is one supplier over here in the UK, that has a rather novel approach in sales incentives. They have their own EMC test facility and if you use parts supplied by them in your design, they will allow you to use their test facility for free. They have a qualified engineer on hand to assist.

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    A note aside:

    We have witnessed here that a lot of Chinese suppliers have been providing "CE" and all kinds of other documents to their customers at sampling stage.

    When the customer(s) tests and approves the samples, they place the order as they have the documents provided by the supplier.

    However, what the suppliers ship are not the same quality as the samples they had provided.

    In order for this kind of supplier to get the approval for CE and other types of standards, they make a real good samples and submit these good samples to the testing labs. The samples pass and get the approval.

    When the customer receives the shipment, the products are still good and do the job with no problem at customer's side. But if you submit a sample from this shipped lot to the labs, it will not pass.

    -------------------
    "If the Earth were a single state, Istanbul would be its capital." Napoleon Bonaparte

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    Quote Originally Posted by lester
    Incidentally, there is one supplier over here in the UK, that has a rather novel approach in sales incentives. They have their own EMC test facility and if you use parts supplied by them in your design, they will allow you to use their test facility for free. They have a qualified engineer on hand to assist.
    Lester, could you expand on this please

    Thanks
    Keith

    www.diyha.co.uk
    www.kat5.tv

  9. #9


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    Quote Originally Posted by Melanie View Post
    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.
    Not actually correct. You must ensure that your product meets all the relevent new approach directives so If it comes under the EMC directive and the LVD directive it must meet both of them. You can't just stick a CE mark on a product because it meets one of the directives

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    As has been stated already - your testing very much depends on the target market.

    There are HUNDREDS of directives. They're not free - you have to BUY them (which is a personal annoyance, because if somebody makes a Law you are forced to comply with - then they should tell you and not force you to splash out $350 just to figure if it applies to you or not). Well if it doesn't, then tough, pick another one and splash out another $350. One product I designed could be classified under TWELVE different directives depending on application. That's $4000 and two days worth of reading just to figure if they apply to you! And you haven't started testing yet...

    Yes, we DO test our products - we have to. I have $50K's worth of equipment sitting at my right elbow just for the purposes of compliance. But that doesn't stop me maintaining that this subject is the biggest waste of time, money and effort on the face of this planet, and that if there is any possible exemption or loophole (eg like stating that your product is for INDUSTRIAL rather than DOMESTIC usage), that you exploit it fully, because rest assured, your competitors will be doing just that.

    Thank Gawd there's no directive (yet) on software... otherwise we'll all be in trouble!

    So, subscribe to the Toyota principle of business:- Kanban? JIT? No, as long as nothing falls off when chewed by a three-year old - it's good to go... If I earned Akio Toyoda's salary, I wouldn't mind grovelling to congress once in a while either...

  11. #11
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    Exclamation Clarifications for CE marking.

    This advice is provided based on my experiences and is not meant to be legal advice.

    Just wanted to clarify some information that I have read in here. Hopefully this will help at least one person out there to avoid making mistakes. I have worked at a test lab for six years and in industry doing compliance for over eight years. I have been on both sides of the testing.

    Currently to CE mark a product you will need to meet ALL applicable directives a stated by ponthirmike. Previously you could just meet the EMC directive for instance and apply the CE mark. (I have tried to find the date of this transition and will post it here once I do.)

    For the Low Voltage Directive (LVD) there are a just a few standards that cover a majority of products. Some of these standards have a part 2 (especially medical) which may apply specifically to your product so don't neglect to check any part two standards.

    EN 60335-1 for Household Equipment
    EN 60950-1 for Information Technology Equipment
    EN 60601-1 for Medical Equipment
    EN 60065-1 for Audio Visual Equipment

    Note: these standards are "harmonized" with US and Canadian equivalents i.e. UL 60950-1, so you can do the testing once with a Nationally Recognized Testing Laboratory (NRTL) with the country specific deviations and obtain approval for US, CAN, and EU. If you need more counties investigate obtaining a CB scheme approval at the same time.

    Complete list http://ec.europa.eu/enterprise/polic...s/low-voltage/

    For EMC Directive standards are listed here:http://ec.europa.eu/enterprise/polic...y/index_en.htm

    If you are doing testing for the EMC directive, for a little bit extra the labs should be able to do your FCC Part 15, and Industry Canada testing at the same time. If you have a radio transmitter in your product, seek the advice of a testing lab if you are not familiar with the requirements.

    If you do not know which standards to use contact a local lab. Ask for a quote to meet the applicable directives for your device. You may want to get a quote from a few labs to make sure they agree on the testing that needs to be done. If you don't agree work with the lab ask for explanations.

    Intertek (ETL), UL, and CSA have labs all over. If you are in Europe, TUV, Semko, Nemko, Demko etc. A helpful lab I have used is ACS ACStestlab.com they do EMC testing and are an agent for some NRTLs.

    Directives are free to view and download. However, the standards that you must comply with to meet the directives cost money. I agree these should be provided free or at cost to manufacturers, but usually a couple of hundred dollars spent on standards could save thousands (or more) if you avoid costly redesigns. Having the applicable standards that apply to your products is important to have during the design phase. Safety standards contain information like spacings required between mains voltage parts and low voltage parts, temperature limits, protection requirements are all included. If you make a mistake during your initial design, delays re-spinning a board or changing your enclosure material because you chose the wrong flammability of plastic could cost a lot in sales in the time you are making these changes.

    Most labs will allow you to come in and view their copy of standards especially if they expect you to bring your business to them.

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    Hi,

    As a lot of of you guys have been through the process could someone please clarify something for me.

    I've been working on a project since December 2009, initially for my own personal use. The device is mains (240v) powered and drives mains heaters at the same voltage. I've just had a small batch of PCB's made to prove the schematic and I'm in the process of making the prototype. I've had lots of interest from others who have suggested that I make these units available on a small commercial basis. My concern is that whilst I'm confident the device is sound and fit for purpose in my own home (the original prototype has been running for almost three months without a problem) I don't want to be responsible or help liable by any 3rd party in the event of a fire or electrocution.

    I gather that any device marketed in the EU needs to be CE approved, and given the fact the previous poster is in the testing / compliance business would like to hear what directives my device should comply with and what the typical cost in getting a mains powered thermostatic device through the testing.

    What would be the implications if I sold such a device privately without any CE certification - is that actually legal now ? I personally don't have the funds to meet any £15K fine and don't fancy spending time inside....

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    Quote Originally Posted by GaryAviation
    Hi, I have a problem and I am getting no assistance from the EU, their Market
    Surveillance folks - nobody.
    Hi,

    Not surprising.
    Same as "I don't get help from the legislator and the court judge for my case of drunk driving".
    Two options, hire a lawyer or defend yourself without a lawyer.

    See these links:
    http://www.ce-mag.com/suppliers/cat/341.html

    Best regards,

    Luciano

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    Quote Originally Posted by GaryAviation
    .. He says that equipment being used "ON" the aircraft means that it flies with the aircraft. Our equipment is used on the ground, on the aircraft to test and verify.

    If we decide to self certify our equipment (which I beleive it will pass) what standard(s) should we use? Is there a general standard that is easy to pass? Or is there some special standard we must use because we sell test equipment used on aircraft? Anyone have any ideas??
    Well,well... Generally any equipment used in aircraft manufacturing process (and testing) needs to be certified..

    If u're about 95%, or say at least 80%, sure that nobody wont get killed after that equipment of yours been used to test that crashed aircraft, I'd say it's pretty safe to put that self certified CE-sticker in it and never bother your head with the matter again.. I know that this is the way things have been done for last 10 or 15 yearsin in some "southern countries of Europe" - they do write those CoC's without any quilt.. then again - if u need to play safe, then it just might be a good idea to do some homework.. one rule: list all standards your equipment meets, and if you are not 100% sure - don't list it..

    Personally u're pretty safe as long as you don't put your signature into any piece of paper (CoC).. That does not acquit your boss and the company u work in.. If you have already signed even one CoC, then your ass is mine.. be sure that once your ass is on the line-some sunny day someone will burn _your_ ass... o:-)

    And if u ever quote me, I'll straightforwardly deny everything... o:-)
    Last edited by oldtoddler; - 12th March 2006 at 21:18.

  15. #15
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    Default Change in Standard #s ??

    Folks: Thanks to all who replied to my question(s) on CE certification. I took your advice and ordered EN 50082-1 and EN 50082-2. PROBLEM ?? I did not receive either. I received the following:

    BS EN 61000-6-1:2001 and BS EN 61000-6-2:2005

    Are these two officially replacing the EN 50082-1 and EN 50082-2? And on my self certification document, I can simply list one of these and call it a day?

    Thanks

  16. #16
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    Default They have us running scared

    Quote Originally Posted by Melanie
    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so.
    Melanie, You are actually in the UK right? I say that because those of us across the pond (USA) have been given a much more restrictive warning about CE marks. I sold a product to Darsbury University and needed the CE mark. I "self" certified as is allowed and saved the $8000 EMC and Low Voltage directive testing, but I really felt like I was pushing my luck. Everything I read about CE indicated that I needed to check off ALL directives that the product fell under and then show that the product met ALL directives before affixing the mark. (sidebar- can you believe there are companies selling the gif image for CE? As if we can't find the image elsewhere and photoshop it.)

    I think the fear is not that some postal inspector will catch you, but rather the fact that one of your EU competitors might rat on you to the authorities in order to get your product banned.

    I would love to have you dissuade my fears, because I just got a quote from a testing company for a new product. $12500 to certify it for EMC and Low voltage directives.

  17. #17
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    Default Sorry Gary

    To answer your original question -- Yes.

    EN61000:2001 is the new EMC standard.
    I think the sub chapters followed the old 50082 numbers.

    A good web search will yield all the right numbers for you.

    John

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    Speaking as somebody that has been through not only the certification process for products that we manufacture and market, but also as someone who has been through the mill when prosecuted for non compliance under the EMC directive, I think i'm fairly well positioned in saying that:

    Many people attach the CE mark without testing correctly or even understanding exactly what directives apply. They "get way with it" because they are not challenged.

    You do need to test and you do need to understand which directives apply. You are accountable ( not the company, but the signatory on the compliance statement).

    If you are supplying to a gov't agency or any client likely to carry out due dilligence, i.e any one that specifically asks for CE, be sure to ensure that you have thourougly researched the relevent directives.

    (The same applies to RoHS)

    I dont have it to hand, but if you PM me i'll point you to two excellent books that will spell it out for you. And if you like to call me, i'll explain what happenms when OfCom get wind of a non compliant product, via the local trading standards officer or by Govt agency.

    Rememebr that in the UK failure to comply is a criminal office, with a penalty that can include not only a fine but also imprisonment.

    A two year battle resulted in my name being cleared, the company receiving a fine and 15000 GBP in costs.

    And that was related to failure to comply with the legislation on a product that was exempt form CE, under Functionality, use and End User.

    There is also a case in the UK where a company building home PC's for retail sale, used all CE marked parts, but failed to test the fully built product. They assumed that by using CE marked parts they could CE mark the final product, without further testing. WRONG, resulted in 3 MONTHS prison sentence for the company director and a big fine.


    My advice, dont take advise from non qualified peers, anecdotal evidence is no defence. If it all goes pear shaped, the court will not accept "so and so on the forum said it would be OK"

    BUT, you are in the USA, yes? So the importer is the responsible party, and thats your client
    ------------------------------o0o---------------------------------
    I just deleted a whole load of advsie that i'm pretty sure is correct, but i'm not qualified to give. (legal stuff, that i learned during our prosecution)

    PM me or call me if you wish.


    BTW, I learned so much during our prosecution, that ending up with a clear name and paying 15000 GBP, was actually well worth the money (when viewed in commercial terms), made loads of really good contacts, including those on the presecution team, who i'm still in touch with. Even went for a drink with one of them after the case.

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    Default Re: "CE" mark self certification

    The company that I work for is developing a new device. I've idenitified the EMC and LVD directives to be used. I am going to use the standard EN 60204-1 and EN 61010-1 for LVD. I am going to use EN 61326-1 for EMC. My question is can we test under these standards in house. I'm pretty confident about the safty standards. As far as the EMC standard I'm not so sure about. I'm not sure what equipment is needed for that testing or if it would be better to have someone else test it?

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    Default Re: "CE" mark self certification

    You need some fairly expensive gear to test EMC and an RF anechoic chamber, or an open field site in a quiet remote area. It is also difficult to calibrate, ground, get baseline references... and interpret results. Honestly, this one makes sense to contract out, especially if you and not planning on doing the test regularly.

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    Default Re: "CE" mark self certification

    I have to agree that you would need to do the test in a lab but pre-testing can easily be done with a low cost spectrum analyzer and sniffer probes (1000 usd) and is a very useful tool to find the RF hot spots on your design. This can both help you pass the test in the first try and also llimit the costs later to find what is actually the problem if you fails.

    Once you have the EMC-test report (passed or failed) you can easily find the same characteristics with the sniffer probe but the actual levels is not the same. But you can atleast clearly see if the changes you do to the product helps or not.

    Also it is a great tool for production verification to make sure your products comply with the EMC after a while.

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    Default Re: "CE" mark self certification

    Hi all,

    Thank you for some great insights into the CE process.

    I have a question - I import products from China, and sell them on eBay.

    I make sure the products which need CE according to the New Directives have a CE certificate from the manufacturer.

    Is this sufficient? or do I need to certify the goods myself?

    Regards

    Dan

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    Default Re: "CE" mark self certification

    As long as you have a CE certificate from the manufacturer and that certificate is issued by an accredited laboratory, responsibility belongs to manufacturer; and you are required to provide this certificate in case of a concern.

    Usually, the certificate is just a required paperwork; nothing else; and mostly asked by customs.
    No one will try to test your product to see whether it passes the test procedures or not.
    "If the Earth were a single state, Istanbul would be its capital." Napoleon Bonaparte

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    Default Re: "CE" mark self certification

    If the manufacturer is based outside the EU and does not appoint an official Authorised Representative, then the person importing the products becomes responsible for ensuring that they comply with the directive(s) which apply to them. At very least, it is recommended that the importer obtain a copy of the original Declaration of Conformity.

    If the goods is made in China, the person that puts the goods on the EU market is legaly responsible if the goods does not meet the requirements such as intruction books and such. Of course the importer can try to get compensation from the factory... but the EU agencies will go after the importer.

    I would say it depends alot of the quantity and kind of goods. But if I were to import bigger amounts of some product I would definatly ask to get a copy of the lab reports (LVD, EMC and RoHS). If they can not show this it could be a fake CE declaration.

    "No one will try to test your product to see whether it passes the test procedures or not." This statement I really do not agree with. Your products might be tested by government agencies as part of product safety. Lamps, toys and solar chargers have recently been targeted for testing so it happens. In these tests safety, EMC and RoHS have been the major areas of interest.

    In some cases it have resulted in that the product has been recalled from the market and some importers getting a fine for breaking the rules.
    Last edited by Jumper; - 17th November 2012 at 09:08.

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    Default Re: "CE" mark self certification

    Despite all the fear mongering, all you need is a statement of compliance (declaration of conformity) from the manufacturer.
    This is also true for UL/CSA in North America. If anyone ever asks, show the statement. I have been told this by the certification lab I use for products I develop. (TUV Germany)

    There is no expectation of retest by an importer - frankly, most are non-technical and would not know where to start, and if you went to a certification lab they would say "I'm happy to take your money, but there is no need".

    Just file away the certificate and sleep comfortably at night.

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    Default Re: "CE" mark self certification

    Thanks guys, thats useful info

  27. #27
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    Default Re: "CE" mark self certification

    Yes - Jumper is absolutely right - under most of the Directives (some differ slightly - other differ greatly) the importer carries responsibility.

    Please me aware that Enforcement Officers have changed tack. in the 90's they would buy products and test them.

    Now they just ask for documentation. If you don't have a Declaration of Conformity - big problem.

    If you call up the wrong Directives or don't have reports things also get sticky.


    During the last year or so the UK MoD announced they 'require' products to conform consumer regulations and bear the CE Marking IF IT WAS PRACTICAL. Bullets are I believe still exempt.

    G

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