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Medical Device Registration in Slovenia
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Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
Medical Device Registration in Slovenia
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Medical Device Registration in Slovenia


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medical device registration, slovenia
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  Post Number #1  
Old 12th September 2014, 03:53 AM
FR_md24

 
 
Total Posts: 7
Please Help! Medical Device Registration in Slovenia

Dear all,

I am looking for some info about medical device registration in Slovenia.
Is there some specific national notification/registration procedure? A database maybe?

The JAZMP, in its website, states:

"Pursuant to the Medical Devices Act (Official Gazette of the Republic of Slovenia, No 98/09), medical devices must be notified for entry in the register only by:

medical device manufacturers who have their registered office in the Republic of Slovenia;
Manufacturer’s representatives who have their registered office in the Republic of Slovenia."


My main question is:

Does a manufacturer located in the European Union willing to sell a CE marked device in Slovenia must have a representative in Slovenia, which will be responsible for the national registration?

OR

Insertion in the national register is mandatory ONLY for manufacturers/representatives located in Slovenia?



BONUS QUESTION: what about custom made devices?

Thank you very much

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  Post Number #2  
Old 13th June 2016, 07:45 AM
SultanS.

 
 
Total Posts: 4
Re: Medical Device Registration in Slovenia

Hello,

medical devices registration is mandatory only for local manufacturers and authorised representatives.
If you want to sell MD with CE marking in Slovenia, you need to appoint EAR anywhere in EU and sell your product freely.

Best regards
Thanks to SultanS. for your informative Post and/or Attachment!
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