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Kärolin Jenas
Ravimiamet
üldosakonna dokumendihalduse spetsialist

Telefon 737 4140
karolin.jenas@ravimiamet.ee

Nooruse 1
50411 Tartu
www.ravimiamet.ee

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Dear State Agency of Medicines,

We trust this email finds you well.

We are an authorised representative based in Malta and we represent a number of medical device manufacturers all over the world. We are aware that in some EU countries, such as Italy,  the manufacturer will have to submit a notification or register their device on a national database prior to placing the medical device on the national market.

Our questions are the following;

• Does the manufacturer need to submit a notification prior to placing their device on the Estonian Market?

• Do they still need to submit the notification if they are registered on EUDAMED?

• Can the Authorized Representative submit the notification on behalf of the manufacturer?

We look forward to hearing from you and taking you in advance for your time.

Wishing you a fantastic week ahead.

Kindest Regards,