Regulatory Open Forum

Rashmi,

That is not a viable option under CE Marking today and definitely not under the new EU MDR.  After Brexit, who knows how United Kingdom will handle it, but in the greater European Union read Article 16 of the EU MDR - basically any product with the company name on it, they then become the legal manufacturer and need full access to all technical documentation.

A legal manufacturer can also act as a distributor in Europe if they have an affiliate or sister company taking on that role.  This should not be an issue because if the affiliate or sister company is being the legal manufacturer, as the same company they would have full access to the technical documentation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 28-Jan-2020 18:42
From: Rashmi Pillay
Subject: Legal manufacturer as distributor

Hi,

 

The MHRA guidance on 'Virtual manufacturing of medical devices' mentions the possibility of how a virtual manufacturer can change from being the legal manufacturer to the distributor, and also affixing their brand name or trademark on the labelling , based on the agreement between the two. So , in such a case , could you confirm , there is any impact to the certification if the actual manufacturer holds the relevant QMS certification for the product ? Assume the actual manufacturer responsible for CE marking , UDI , post market requirements?

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Manager

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

Original Message------

Rashmi,

That is not a viable option under CE Marking today and definitely not under the new EU MDR.  After Brexit, who knows how United Kingdom will handle it, but in the greater European Union read Article 16 of the EU MDR - basically any product with the company name on it, they then become the legal manufacturer and need full access to all technical documentation.

A legal manufacturer can also act as a distributor in Europe if they have an affiliate or sister company taking on that role.  This should not be an issue because if the affiliate or sister company is being the legal manufacturer, as the same company they would have full access to the technical documentation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Hi Rashmi,

in your reply you are using terminology as 'actual manufacturer', 'specification developer' and ​'brand owner' which are not defined and not used in the MDR. This makes it difficult to have a fruitful discussion on the possible approaches and responsibilities of the Economic Operators within the EU. It would be helpful explaining your case using the available terminology.
Note that e.g. 'producer', 'supplier' and 'subcontractor' are barely mentioned in the MDR and do not have any legal obligations and are mainly mentioned in regard with the responsibilities of NBs.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 29-Jan-2020 05:43
From: Rashmi Pillay
Subject: Legal manufacturer as distributor

Hi Richard,

 

Thanks for your response. If the legal manufacturer being mentioned on the label is the actual manufacturer and specification developer and if the product is manufactured for the brand owner, is there an option that the  actual manufacturer becomes  the  legal manufacturer ?

 

Thanks,

 

......................................................

Rashmi Pillay

Regulatory Affairs Manager

 

T  +61 8 7074 8105

E  rpillay@ellex.com

 

Original Message------

Rashmi,

That is not a viable option under CE Marking today and definitely not under the new EU MDR.  After Brexit, who knows how United Kingdom will handle it, but in the greater European Union read Article 16 of the EU MDR - basically any product with the company name on it, they then become the legal manufacturer and need full access to all technical documentation.

A legal manufacturer can also act as a distributor in Europe if they have an affiliate or sister company taking on that role.  This should not be an issue because if the affiliate or sister company is being the legal manufacturer, as the same company they would have full access to the technical documentation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

What you describe is possible and the biggest distributors in the UK have mostly already done this - just take a look at the labels of some medical devices in your local Boots or Lloyds pharmacies or indeed any of the large supermarkets.
Article 16 states that a distributor becomes a legal manufacturer if his or her name, trade name or registered trade mark appears on the labelling EXCEPT "in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation"
Therefore, as long as you have a distribution agreement in place with the legal manufacturer defining their responsibilities for CE marking, and they are clearly identified as the legal manufacturer on the label, then this is OK. The legal manufacturer should then be keeping copies of the labelling with your branding on it in their technical documentation. You need to be aware that you can't make any changes to the product once it is supplied to you otherwise you may then become the legal manufacturer yourself. I would advise familiarising yourself with the exact wording of article 16 to know what changes can and can't be made.

------------------------------
John Walters
Wells
United Kingdom
------------------------------

Original Message:
Sent: 28-Jan-2020 18:42
From: Rashmi Pillay
Subject: Legal manufacturer as distributor

Hi,

 

The MHRA guidance on 'Virtual manufacturing of medical devices' mentions the possibility of how a virtual manufacturer can change from being the legal manufacturer to the distributor, and also affixing their brand name or trademark on the labelling , based on the agreement between the two. So , in such a case , could you confirm , there is any impact to the certification if the actual manufacturer holds the relevant QMS certification for the product ? Assume the actual manufacturer responsible for CE marking , UDI , post market requirements?

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Manager

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

 

 

 

 

Original Message------

What you describe is possible and the biggest distributors in the UK have mostly already done this - just take a look at the labels of some medical devices in your local Boots or Lloyds pharmacies or indeed any of the large supermarkets.
Article 16 states that a distributor becomes a legal manufacturer if his or her name, trade name or registered trade mark appears on the labelling EXCEPT "in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation"
Therefore, as long as you have a distribution agreement in place with the legal manufacturer defining their responsibilities for CE marking, and they are clearly identified as the legal manufacturer on the label, then this is OK. The legal manufacturer should then be keeping copies of the labelling with your branding on it in their technical documentation. You need to be aware that you can't make any changes to the product once it is supplied to you otherwise you may then become the legal manufacturer yourself. I would advise familiarising yourself with the exact wording of article 16 to know what changes can and can't be made.

------------------------------
John Walters
Wells
United Kingdom
------------------------------

Hi John,

Based on your experience , if the virtual manufacturer (XYZ) in the above scenario , requests the legal manufacturer to have the virtual manufacturer 's name as 'Manufactured for  XYZ' , Distributed by : ABC ( another company appointed for distribution by XYZ). Does this impact  the scope of the CE certification ? The legal manufacturer's name and address will not be impacted.

Thanks

Rashmi


------------------------------
Rashmi
------------------------------

Original Message:
Sent: 03-Feb-2020 06:15
From: John Walters
Subject: Legal manufacturer as distributor

What you describe is possible and the biggest distributors in the UK have mostly already done this - just take a look at the labels of some medical devices in your local Boots or Lloyds pharmacies or indeed any of the large supermarkets.
Article 16 states that a distributor becomes a legal manufacturer if his or her name, trade name or registered trade mark appears on the labelling EXCEPT "in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation"
Therefore, as long as you have a distribution agreement in place with the legal manufacturer defining their responsibilities for CE marking, and they are clearly identified as the legal manufacturer on the label, then this is OK. The legal manufacturer should then be keeping copies of the labelling with your branding on it in their technical documentation. You need to be aware that you can't make any changes to the product once it is supplied to you otherwise you may then become the legal manufacturer yourself. I would advise familiarising yourself with the exact wording of article 16 to know what changes can and can't be made.

------------------------------
John Walters
Wells
United Kingdom

Original Message:
Sent: 28-Jan-2020 18:42
From: Rashmi Pillay
Subject: Legal manufacturer as distributor

Hi,

 

The MHRA guidance on 'Virtual manufacturing of medical devices' mentions the possibility of how a virtual manufacturer can change from being the legal manufacturer to the distributor, and also affixing their brand name or trademark on the labelling , based on the agreement between the two. So , in such a case , could you confirm , there is any impact to the certification if the actual manufacturer holds the relevant QMS certification for the product ? Assume the actual manufacturer responsible for CE marking , UDI , post market requirements?

 

Thanks & Regards,

 

Rashmi Pillay
Regulatory Affairs Manager

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

 

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.