Understanding Requirements for CE Marking and Test Requirements

O

oemdeveloper

#1
We are a manufacturer of computers used in OEM and specialty applications. Most of the systems we build are not certified (UL, FCC, etc.) but we do build several medical devices, which are certified, so we are quite familiar with third party testing.

We have clients that are going to be selling their products (non-medical) in Europe and will clearly require a CE mark.

Every 3rd party testing house we have spoken with has stated that we need to have at least two tests done on the systems; EMC and safety (low voltage directive). Then we will have the necessary documents to put in our technical file, which we will still have to create. The cost for this testing is always right around $15,000.

We came across an alternative plan in the form of Barclay-Phelps. We contacted them and paid a small fee to have them review our application. Their response was that our systems would NOT require 3rd party testing and that for a very reasonable cost they could put the necessary paper work in order for us and we would be all set. (We build these systems from motherboards, drives and the like, not descrete components. These parts have FCC, CE and other certifications.)

We have been unable to validate that this is a legitimate way to go. Barclay won't explain further how their methodology works and contacts at 3rd part testing houses continue to say Barclay-Phelps' method is bunk.

The testing guys all have a stake in this game - $15,000 or more in testing. I don't trust their answers. The Barclay approach (cemarking.com is another in the same vein) seems incomplete. What is the right, and cost effective path?
 
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W

w_grunfeld

#2
In my opinion the testing guys are right (almost) you have to test your equipment, not to the Directives but to harmonised standards listed in the respective directives.
For instance you are required to test against EN 60950 -Safety of Information Technology Equipment Including Electrical Business Equipment, which provides "presumption of conformance" with the LVD. In my opinion, the Directive itself does not mandate third party test house but in practical terms it is not likely that you have in-house all the required equipment, know-how, calibration certificates etc. so your TEST CERTIFICATE and TEST REPORT pass the scrutiny of authorities.(in case they'll want to review). Likewise, EMC tests require special anechoic chambers that you are unlikely to have in-house. So the bottom line is that CE in your case is based on self-declaration but it must be based on valid test results and certificates.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
We are a manufacturer of computers used in OEM and specialty applications. Most of the systems we build are not certified (UL, FCC, etc.) but we do build several medical devices, which are certified, so we are quite familiar with third party testing.

We have clients that are going to be selling their products (non-medical) in Europe and will clearly require a CE mark.
Hi,

The last sentence I left in the quote above left me a bit puzzled. it sounds as if those clients fall under the OEM domain you described above, i.e. your products would be first integrated into theirs, then *they* would be placing them on the EC market - is that correct? If so, your products do not require CE marking per-se. It would probably be a very handy added value for your clients (and might also become a contractual obligation if you so agree in the contract), but from a regulatory standpoint it is not a requirement. It would be your clients' responsibility to meet all applicable requirements (testing and other) with *their* products, including the components they get from you, in finished device form.

Second, as a general note, I wouldn't trust any non-1000% transparent consultancy firm, e.g. one that doesn't do *everything* in its capacity to have me informed and satisfied with regards to any and all of their processes, rationales and practices. Just to clarify, I have no affiliation whatsoever with any electrical test laboratory.

Cheers,
Ronen.

PS By your phrasing above, I assume you meant those clients are located outside Europe and selling into the EC.
 
O

oemdeveloper

#4
Thank you for your comments. Ronen, you have touched on something that has occured to me; why not let our customer deal with the CE issue? I've always assumed that we would handle any needed certifications because that is the way historically our customer's have preferred it. If our client is comfortable with Barclay-Phelps approach and puts the necessary documentation into place, we would only be putting CE marks on the system at thier request. Our name is not on the product at all so all responsibity would lie with our customer.
 
I

imajeenyus

#5
Hello,

I'm currently going through the process of getting a small electronic product CE marked (I'm in the UK) and, at the moment, I'm pursuing Barclay-Phelps to see what they can offer. Like yourself, I was a bit mystified as to how they can avoid the need for third-party testing, since everything I've read indicates this is an absolute requirement. I'm filling out the initial questionnaire, but I was wondering if you could share any more of your experiences with B-P? Did you go with them eventually for CE marking or did you use a testing house? What sort of job did they do?

It seems impossible to find any information about who they are (you'd think they'd at least have an "About us" page on their site).

Would be very grateful for any comments!

Best regards,

Lindsay Wilson (Mr.)
 
I

Ima Mauer

#6
I'm not sure if this is the place to ask a new question but here goes:

We are looking at CE marking for a class I medical device -not sterile and does not measure. This is my 1st time working with CE. My understanding is we can self declare by completing the required documents. My questions are what testing is required and how long does that usually take if required. What is the timing from submitting documentation to getting the approval to apply a CE Mark? Do I need to register with a 3rd party. Any help or commnet is appreciated...Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I'm not sure if this is the place to ask a new question but here goes:

We are looking at CE marking for a class I medical device -not sterile and does not measure. This is my 1st time working with CE. My understanding is we can self declare by completing the required documents. My questions are what testing is required and how long does that usually take if required. What is the timing from submitting documentation to getting the approval to apply a CE Mark? Do I need to register with a 3rd party. Any help or commnet is appreciated...Thanks
Hello and welcome to the field :bigwave:

Have a read:
 

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Ronen E

Problem Solver
Staff member
Moderator
#8
I'm not sure if this is the place to ask a new question but here goes:

We are looking at CE marking for a class I medical device -not sterile and does not measure. This is my 1st time working with CE. My understanding is we can self declare by completing the required documents. My questions are what testing is required and how long does that usually take if required. What is the timing from submitting documentation to getting the approval to apply a CE Mark? Do I need to register with a 3rd party. Any help or commnet is appreciated...Thanks
In short:

- Required tests and their duration would depend on the nature of your device.

- You don't need to "submit documentation" and "get approval to apply a CE mark" for a non-sterile non-measuring class I device. Once you comply with all the applicable requirements, you're good to go (self-certification).

- You will have to register your class I device(s) with one of the Competent Authorities in the EC. Any manufacturer who doesn't have a registered place of business in one of the EC member states has to nominate an EC authorized representative; this EC rep will handle the registration on your behalf. Once they submit you should get the confirmation in a month or less.

Cheers,
Ronen.
 
W

w_grunfeld

#9
Ronen,
I agree with the first part of your answer but the second part contradicts the first. The CE mark in this case being based on self declaration, what "Authorities" do you refer to? There are no authorities involved. EU representative is a different matter altogether. It can be the importer or anyone they appoint to play this role
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Ronen,
I agree with the first part of your answer but the second part contradicts the first. The CE mark in this case being based on self declaration, what "Authorities" do you refer to? There are no authorities involved. EU representative is a different matter altogether. It can be the importer or anyone they appoint to play this role
MDD:

Article 14
Registration of persons responsible for placing devices on the market
1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.
(...)
2. ... For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.
(Emphasis added)

Article 11
Conformity assessment procedures
(...)
5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking...
 
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