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23rd May 2008, 11:51 AM
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Is CE Re-Certification Necessary? - Add internal cooling fan
I would like some help. We have an existing medical unit which has been Certified for CE. We would like to add a internal fan for additional cooling, because of this the shape, size and weight will change. Is CE Re-certification testing nessesary?
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23rd May 2008, 11:55 AM
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Re: Is CE Re-certification nessesary?
Oh, if only we understood CE marking/requirements. 
I am not going to even try to pretend to know the answer, but I surely wish that this whole program was easily understood.
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23rd May 2008, 12:11 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
Quote:
Originally Posted by WBubel
I would like some help. We have an existing medical unit which has been Certified for CE. We would like to add a internal fan for additional cooling, because of this the shape, size and weight will change. Is CE Re-certification testing nessesary?
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I am not an expert in this field either, however, going under the assumption that you have changed the design, weight, and function (in Aerospace terms: Form, fit and function is affected), common sense would tell me you would need to re-certify the product.
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23rd May 2008, 12:31 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
I'm also not an expert in the medical device directives, but based on my experience with the directive I work with and the sometimes odd logic in my head, I would say "it's likely" because adding a fan would impact the power distribution of the whole unit, wouldn't it? And you'd have prove that this addition will not cause failure of any other subsystems?
Best bet would be to contact your NOBO and give him a "what if". At the very least your NOBO has to approve the change, right?
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23rd May 2008, 12:43 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
Function of the Device does not Change. Color may also change. We test to IEC 60601-1
Last edited by WBubel; 23rd May 2008 at 01:00 PM.
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23rd May 2008, 12:45 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
Quote:
Originally Posted by WBubel
Fuction of the Device does not Change.
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However, Form, weight and fit does, correct?
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23rd May 2008, 01:02 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
Yes, Form, weight and fit changes.
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23rd May 2008, 01:12 PM
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Re: Is CE Re-Certification Necessary? - Add internal cooling fan
Quote:
Originally Posted by WBubel
Yes, Form, weight and fit changes.
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Then I still would go by my common sense and say that the product needs to be re-certify (better safe then sorry). But, as I said, I am not an expert on this subject matter.
Maybe some of our CE subject matter experts can help with this question.
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