Regulatory Open Forum

If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
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Courtney Clark
Regulatory Affairs Specialist III
United States
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Clark -

This is a bit of a general question. I would say watch out for facility registration and any complaint tracking/device reporting requirements. There will still be a level of compliance required to distribute another's device even if the label indicates it was made for your company.

Feel free to e-mail me if I can help with any specific questions.

Best,

Marc


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Marc Sanchez
Attorney and Consultant
Atlanta GA
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
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Courtney Clark
Regulatory Affairs Specialist III
United States
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Generally, no. The MDD states the responsible entity is the one "placing onto the market" - in other words the name and address of the entity on the label. This means you must thru Supplier Controls manage the product quality and it's specification, and document the required CE dossier under your name ( Product Family Description, ER Checklist, Clinical Assessment, Risk Assessment, Declaration of Conformity, etc.)
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Carroll Hoyle
Global Regulatory Affairs
BSN Medical
Rutherford College NC
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
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Courtney Clark
Regulatory Affairs Specialist III
United States
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Yes, in general you can.  However, there is also a significant business concern here.  For instance, in order to use their CE Mark, you should have a supplier agreement in place which states that the manufacturer authorizes you to use their mark, that their Authorized Agent  (or the company themselves if located in Europe) agree to carry on that responsibility for you, and that they will be responsible for any Notified Body or Competent Authority reporting.  So, while you can use their mark, there are many details which need to be addressed.

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James Bonds
Director Regulatory Affairs
Livermore CA
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
-------------------------------------------
Courtney Clark
Regulatory Affairs Specialist III
United States
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The CE mark is applied by the entity that is taking responsibility for meeting the essential requirements of the applicable directive(s) and commercializing the device in Europe.  The entity taking this responsibility is identified as the "manufacture".

 

The CE mark of the contact manufacturer could be applied if they are commercializing the device in Europe and labeling the device as "manufacturer".  If your company is commercializing the device in Europe, under your company name, then your company is the manufacturer for Europe with your company's CE mark. 

 

For FDA compliance, we have used the EN 980 standard CE symbol for "manufacturer" and the FDA reference of "manufactured for" on labeling, in this example using your comany's name adn CE Mark as the manufacturer.

 

Hope this helps.
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Gary Syring
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
-------------------------------------------
Courtney Clark
Regulatory Affairs Specialist III
United States
-------------------------------------------

Courtney,

It is possible to use the manufacturer's CE mark, but a few things have to happen first to make that kind of setup compliant. It also depends upon the product and it's classification. We do use a manufacturer's CE mark for one of our products that requires Notified Body involvement. We had to be audited for CE mark, and we also had to have a summary Technical File. We also have an Own Brand Labeling agreement with them. You should talk to your supplier and find out what they normally do, especially if you're not the only company they're making product for for the EU market.

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Paula Bojsen
Ranir
Grand Rapids, MI
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
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Courtney Clark
Regulatory Affairs Specialist III
United States
-------------------------------------------

Hi Courtney,

As Paula mentioned, you can place a device in the market in the EU with your company as the legal manufacturer as defined in the Medical DEvices Directive under an Own Brand Labelling agreement and OBL certificate issued by a Notified Body if the device requires a NB intervention.  The necessary Technical, Quality and Regulatory agreement(s) must be in place.  If your company uses the same NB as the manufacturer they may even not require an audit.  Your company's address will then be next to the EN 980:2008 manufacturer symbol.  You will also require an Authorised Representative in the EU if you don't have an office based in the EU.

You can also place the device in the market as "The Distributor", on the label indicated as "The Distributor" and the "Legal Manufacturer" still indicated as the manfucturer on the labelling.  With this scenario you would also require the necessary Technical, Quality and Regualtory agreement(s) to be in place to ensure vigilance and traceablity.

Kind regards,
Elizma.

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Elizma Parry
Group Regulatory Affairs Manager
Advanced Medical Solutions Plc
Winsford
United Kingdom
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Original Message:
Sent: 11-01-2011 12:06
From: Paula Bojsen
Subject: Using a supplier's CE mark


Courtney,

It is possible to use the manufacturer's CE mark, but a few things have to happen first to make that kind of setup compliant. It also depends upon the product and it's classification. We do use a manufacturer's CE mark for one of our products that requires Notified Body involvement. We had to be audited for CE mark, and we also had to have a summary Technical File. We also have an Own Brand Labeling agreement with them. You should talk to your supplier and find out what they normally do, especially if you're not the only company they're making product for for the EU market.

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Paula Bojsen
Ranir
Grand Rapids, MI
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
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Courtney Clark
Regulatory Affairs Specialist III
United States
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MHRA has a document that might address this for you: OWN BRAND LABELLING AND RENTED PRODUCTS BULLETIN No. 19.  We do this for some of our contract customers. 

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Lisa Derrick
Director QA/RA
Endo-Therapeutics, Inc.
Clearwater FL
United States
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Original Message:
Sent: 10-31-2011 16:38
From: Courtney Clark
Subject: Using a supplier's CE mark


If you have a product manufactured by another company and the label states "Manufactured for your company", can you use their CE mark to sell the product in the EU?
-------------------------------------------
Courtney Clark
Regulatory Affairs Specialist III
United States
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