CE Marking Medical Devices - Country Requirements

ISO 13485 - Medical

Involved In Discussions
#1
Although the CE mark placed on a medical device, with for Class 1 or via a notified body allows you to sell in Europe, can anybody tell me if there is any specific country requirement within European countries for registering you product for to allow it to be sold?
 
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somashekar

Staff member
Super Moderator
#2
Although the CE mark placed on a medical device, with for Class 1 or via a notified body allows you to sell in Europe, can anybody tell me if there is any specific country requirement within European countries for registering you product for to allow it to be sold?
Yes. If you are out of the EU, your AR would help you out with this. However I am not sure if such product registration is a requirement in every EU country.
 
K

kanwal

#3
Article 14 Para 2 requires that the Authorised Representative shall advise the Competent Authority where the AR is located of
1. the registered office of the AR
2. list of devices placed and their description.

Kanwal
 

lilybef

Involved In Discussions
#5
We have found that some countries require an application to accompany the notification letters sent by our Authorized Rep. The Czech Republic for one. Our AR sends us the applications to complete.
 
V

Vincnet

#6
The short answer is yes, depending on the country the requirements are different.

Just for illustration and not thorough:
- Portugal, Italy require a specific registration in their data base with fees for italy;
- according to the type of product you might have to send a registration in France, Belgium, Netherlands.

you need to check on a product/country base.

I can provide help should you need it.

V
 
T

Tiffany

#7
Hi,

For my company, the EAR is also our y sister company. This sister company only is only a sales office which only have a staff there.

And i do not think that he is competent to have the knowledge in product registration EU.

What shall we do in this case and how should I register our medical devices in EU although we have long time enough obtaining CE Mark.

Tiff

:thanx:
 
K

kanwal

#8
Apparently your sister company is not an EAR in the sense denoted by the EU Directives, rather it is only a sales office as stated in your post.
A clear picture is required to comment further.
Answers to the following may be provided -
1. Are you selling the products in EU under your name?
2. Is your CE Mark certification completed?
 
K

kanwal

#10
Check your technical file approved by the NB for the name of the EAR nominated by your company.
The name of the EAR should also be appearing on your labels. Annex 1 Para 13.3 (a) MDD.
If your product is not class 1 - the NB would have done the necessary intimation to the CA. So no worry.
 
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