Medical Device Registration in Slovenia

F

FR_md24

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 :bigwave:
 
S

SultanS.

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
 
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