C
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?
Any thoughts/experience would be very much appreciated.
Claire
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?
Any thoughts/experience would be very much appreciated.
Claire