FEE Registration LINK - EU Medical Device

S

sree.sree

#1
Hai... folks,

Please share the FEE Registration LINK for EU Medical device.


Thanks in advance.
 
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pkost

Trusted Information Resource
#2
What is FEE registration? do you mean a link for the payment of fees related to registration, similar to the FDA furls system?

It doesn't work in quite the same way for EU, where registration is necessary with a competent authority then each country will have it's own system and costs. For higher risk devices that require a notified body to review, then you will have to select and appoint one of your choosing

I'm not sure if this answers your question, please give me details
 
S

sree.sree

#3
many thanks for your concern.

Yeah u r right!

k,then (except UK ) share the Registration link of any country/competitive authority in Europe
 

Marc

Fully vaccinated are you?
Leader
#4
You would be better off asking for links to specific countries you are interested in. There are a lot of countries in Europe.
 

pkost

Trusted Information Resource
#5
A list of competent authorities can be found here:
Contacts - European Commission

Its important to note:
1. You only need to "register" in one country, this then opens the door to the rest of Europe. This is where your company is based, or if you are outside of the EU, normally where your EC rep or notified body is located

2. There are some countries (Italy comes to mind) that require you to inform them of any products you place on the market


As Marc indicated, it would be better if you detailed specific countries
 
S

sree.sree

#6
thanks for your concern sir..,:thanx:

if we wana register in Denmark,Germany...plz provide the link for registration which has fee structure....
 

pkost

Trusted Information Resource
#7
Germany doesn't have any requirement to inform them of products you are placing on the market unless you/EC rep are in Germany. From recollection they do have some quirks such as appointing and nominating specifically qualified vigilance person (or something like that).
I don't know the costs or how to register as a manufacturer based in Germany

I'm afraid I don't know anything about denmark
 
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