SBS - The best value in QMS software

CE marking for OEM Brand

RAQA Support

Supporting your goals and objectives since 1989.
#11
We are the OEM manufacturer for brand owner located in EU. However, the brand owner wants us to put our company name as the manufacturer and their brand on the product packaging and asked us to do all registration, CE marking and wants to use our importer to bring in the product to Europe. They also want us to put their company name as the distributor. Is it possible for the brand owner to also play a role as distributor? Also, is it possible for us to do product registration and CE marking for other brands which are trademarked by other companies?
In answer to your two questions:
1. The brand owner has a different definition than distributor in the regulations. In my experience with clients in your situation, it sounds like they are trying to put all the regulatory cost and product liability into your system and they become distributors of the product in name only. In this case you are responsible if anything goes wrong with the products and are responsible for all registrations and annual upkeep. Lastly, you would be responsible for maintaining the design and associated files of the product. This is a common hand-off and easy to do as long as you are aware of the implications.
2. Trademark and product registrations are two completely different systems. The trademark is who legally owns the right to use the design. The registration is notifying the government that you will be placing it on the market. Yo answer your question, yes you can do the registration for products that are trademarked by others. The issue becomes complicated only because in order to perform the registration, you must supply product documentation that they may consider company confidential. I would recommend making sure you have access to all documents prior to starting the process.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
O OEM vs. Supplier - CE Marking EU Medical Device Regulations 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
G CE marking of MD and IVD set EU Medical Device Regulations 3
M CE marking for NON-EU EU Medical Device Regulations 0
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
S CE marking for a product upgrade CE Marking (Conformité Européene) / CB Scheme 0
P CE Marking UK Membership CE Marking (Conformité Européene) / CB Scheme 1
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Clinical investigations of medical devices - not for CE marking EU Medical Device Regulations 0
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
Ed Panek Is Shelf Life Change a significant change? CE Marking CE Marking (Conformité Européene) / CB Scheme 7
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
P CE Marking EN ISO 13849-1: Electrical Panel behind interlocked doors CE Marking (Conformité Européene) / CB Scheme 9
M Cleaning Process after laser marking on orthopaedic implants Other Medical Device and Orthopedic Related Topics 3
H Safety and efficacy study for CE marking CE Marking (Conformité Européene) / CB Scheme 1
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
J CE Marking for vibrator personal pleasure toy CE Marking (Conformité Européene) / CB Scheme 16
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
E Safety work instruction if the equipment have the CE Marking and a Manual with safety instruction Various Other Specifications, Standards, and related Requirements 16
Z Direct Part Marking (DPM) requirements for Class II Medical Devices Manufacturing and Related Processes 0
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
J Virtual Manufacturer and CE Marking EU Medical Device Regulations 8
N CE marking for distributed product CE Marking (Conformité Européene) / CB Scheme 1
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
J Class 1 CE Marking - Can this be removed from the label on the product? CE Marking (Conformité Européene) / CB Scheme 4
I Tool Control Marking Voiding Warranty AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158 Other US Medical Device Regulations 2
K UDI Direct Marking Compliance Date Clarification and one other UDI question Other US Medical Device Regulations 0
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18

Similar threads

Top Bottom