Medical Devices and Licensing of Trademark to an OBL in UK

C

claireyvb

#1
For UK Medical Device market only:

Scenario: Company A, a UK OBL, buys a class IIa Medical device from an OEM, applys CE mark, registers with a notified body, hence becomes "legal manufacturer".

Company B, also in UK, wants to purchase this medical device from Company A as a complete device with Company B's Trade mark already printed on this product so that Company A retain the "legal Manufacturer" status

An agreement to license Company B's Trade mark to Company A and define responsibilities etc. is put in place between the two companies.(http://www.mhra.gov.uk/Howweregulate/Devices/Ownbrandlabelling/index.htm)

Company A, the legal manufacturer would be identified using EN980 symbol - the only reference to Company B would be the trademark.

Has anyone had any experience of this scenario? Is it possible and more importantly in compliance with the MDD regulations? :confused:

Any thoughts/experience would be very much appreciated.

Claire
 
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somashekar

Staff member
Super Moderator
#2
For UK Medical Device market only:

Scenario: Company A, a UK OBL, buys a class IIa Medical device from an OEM, applys CE mark, registers with a notified body, hence becomes "legal manufacturer".

Company B, also in UK, wants to purchase this medical device from Company A as a complete device with Company B's Trade mark already printed on this product so that Company A retain the "legal Manufacturer" status

An agreement to license Company B's Trade mark to Company A and define responsibilities etc. is put in place between the two companies.(http://www.mhra.gov.uk/Howweregulate/Devices/Ownbrandlabelling/index.htm)

Company A, the legal manufacturer would be identified using EN980 symbol - the only reference to Company B would be the trademark.

Has anyone had any experience of this scenario? Is it possible and more importantly in compliance with the MDD regulations? :confused:

Any thoughts/experience would be very much appreciated.

Claire
Technically it is possible. Company B is the distributor for company A. Company A obviously the legal manufacturer creates an other label and retains on it all the requirements of product reference on it per the OBL CE certificate that Company A has. If company A has no agreements established with the OEM about how Company A would market products, it is better to have one made as the design owner is the OEM. It would be better to have a good three party understanding of how the business process is established. We have been successfully doing this way since last 3 years ...
 
C

claireyvb

#3
Thanks Somashekar :). May I ask your advice on which company customers should contact with complaints...

In the pharmaceutical industry Company B would receive the complaints and immediately forward them on to company A, I am unsure in this instance
 

somashekar

Staff member
Super Moderator
#4
Thanks Somashekar :). May I ask your advice on which company customers should contact with complaints...

In the pharmaceutical industry Company B would receive the complaints and immediately forward them on to company A, I am unsure in this instance
The customer has the option to contact company A as the label will have company A marked as the manufacturer. It could come to you even through company B, if the customer first approaches B since he is the direct contact to the customer.
 
C

claireyvb

#5
...and in the instance where the customer contacts company B, is there any requirement to have complaint systems that comply with ISO 13485/MDD and staff trained in ISO 13485? Would it suffice to have Company B's complaint handling/reporting requirements, as defined by Company A, formally stated in the agreement between the two companies?
 

somashekar

Staff member
Super Moderator
#6
...and in the instance where the customer contacts company B, is there any requirement to have complaint systems that comply with ISO 13485/MDD and staff trained in ISO 13485? Would it suffice to have Company B's complaint handling/reporting requirements, as defined by Company A, formally stated in the agreement between the two companies?
That is purely between A and B. However if a complaint does reach a competent authority, then company A stands responsible to make all required satisfactory response in a timely manner. Always it remains company A's product, and with the company A having the CE (OBL route), they are obligated to respond per MDD requirements
 
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