Sanjay,
It is not specific in the regulations, but is generally understood the "Manufacturer" listed on the device labelling is fully responsible for the quality and regulatory aspects of the device. Other than that, there is no requirements for Brand Names or Logos on the device packaging and labelling (except of course any brand name or logos which implies claims for the product which need to be supported). There are nuances involved with private labelled products and self-branded products, but the core expectation is the company listed as the Manufacturer is responsible for the finished medical device. If different brand names or logos are used in different countries or with different partners this gets into other areas such as agreements, contracts, and how the product is marketed in different countries. It is a bit more than could be described here in this forum, but there are different ways product branding can be done yet still maintain compliance; is this essential true for any medical device regulated country.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Jan-2023 05:05
From: Sanjay Singh
Subject: euMDR Customer Brand name & Logo.
Hi all,
We have CE certification as per latest euMDR Now we are started for product sale in European country and other country with CE marking symbol.
Now to many other country customers required his Brand Name or logo on our manufactured product (Class IIa) - Are there any labeling requirements or document required to mention customer brand name or logo on packaging material as per euMDR? Or is it enough to label the brand name or logo on packaging label and sale the product with CE Marking because product is manufactured by us.
Thanks!
Sanjay
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Sanjay Singh
462022
India
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