Regulatory Open Forum

My company produces Class IIa devices.  We sell them to a company located in Europe, who markets the devcies under their name (Private Label).  This company is not certified to the MDD.

We just received approval from our Notified Body to have the Private Labeler put their name and address on the label, along with "Manufactured By" our name and address, with our NB's CE #.  Our NB will not let the marketing company "use" their CE #, unless the relationship between us and the marketer is clearly shown on the label.

Since the Private Labeler is the "Manufacturer" by MDD definition (they are marketing the device) they are responsible for it.  Thus, they should have an agreement with the company producing the device, that determines responsbility for meeting the various MDD requirements - Technical File access by regulatory authorities, Vigilance/Reporting, complaint feedback and handling, etc.

Since much of our Technical File information is proprietary, our stance is that we do not provide it to the Private Labelers, but will provide it to regulatory authorities directly, if requested.

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Timothy White
Leadership, Quality Assurance
Abrasive Technology, Inc.
Lewis Center OH
United States
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As long as the marketer is not the EC-Rep of your company and just the distributor, the whole responsibility is up to the physical manufacturer (your company) even your CE # is shown on the labeling. So it should be enough for the "private labeler" to receive the CE-Cert and DoC from your company for this product.
The "marketer" is not automatically the manufacturer according to the MDD, if he is distributing the Medical Device only.
If the Marketer would be shown on the labeling as the physical manufacturer, you have to provide the techfile to them. Hope this makes sense to you!

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Renate Faust
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Original Message:
Sent: 11-02-2011 09:20
From: Timothy White
Subject: Using a CE #


My company produces Class IIa devices.  We sell them to a company located in Europe, who markets the devcies under their name (Private Label).  This company is not certified to the MDD.

We just received approval from our Notified Body to have the Private Labeler put their name and address on the label, along with "Manufactured By" our name and address, with our NB's CE #.  Our NB will not let the marketing company "use" their CE #, unless the relationship between us and the marketer is clearly shown on the label.

Since the Private Labeler is the "Manufacturer" by MDD definition (they are marketing the device) they are responsible for it.  Thus, they should have an agreement with the company producing the device, that determines responsbility for meeting the various MDD requirements - Technical File access by regulatory authorities, Vigilance/Reporting, complaint feedback and handling, etc.

Since much of our Technical File information is proprietary, our stance is that we do not provide it to the Private Labelers, but will provide it to regulatory authorities directly, if requested.

-------------------------------------------
Timothy White
Leadership, Quality Assurance
Abrasive Technology, Inc.
Lewis Center OH
United States
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