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Medical device name in different countries

#1
I have EC certificate for my medical device but it does not contain device name. Only general scope is included: "therapeutic device for XXX". Does it mean that I can register medical device with different names on different countries (e.g. in Germany this device would have name A, but in Poland - B)?
Thanks for the answer, I am poisoned by the volume of irrelevant information on the internet :D
 
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Cybel

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#2
Hi,

according to my experience, the EC Certificate should contain the device names. In my MDD certificates we have names, codes and trademarks for each model belonging to the family to which each certificate applies. I would be happy if I can only have a general scope and add a new tradename and trademark each time a customer asks for it, but I can't: each time I have to ask for an extension to my NB.
(My MDD certificates are according to annex II excluding section 4. I don't have experience of others).

Anyway, MDR explicitly foresees that the devices are identified by name, trade name and trade mark, so no reason why the EC certificate will be different.
 
Last edited:
#3
Thanks for the answer @Cybel ! It makes sense.
I wonder, how about the situation where the distributor renames the device in particular market? Article 16 of MDR says that such distributors would on need to undergo certain tasks like inform local authorities and implement QMS. But it doesn't say that it effect EC certificate or me (a manufacturer) anyhow.

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Cybel

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#4
If a distributor makes available on the market a device under its name he will assume the obligations of manufacturers (first line of the screenshot you've posted), so, from my understanding, he will have to apply to a notified body for conformity assessment and he will get a new certificate with a new name.
If there is an agreement with the manufacturer and, according to this agreement, the manufacturer is still identified as such, the manufacturer will be responsible for respecting the regulation, so for arranging to include the new device name in its documents, DoC and certificate.
 
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