Kiri

De : Meditsiiniseadmed (Medical Devices) <[email protected]>
Date : mercredi, 3 avril 2024 à 14:42
À : Guillaume Valenzuela <[email protected]>
Objet : Vs: registration of a new medical device in Estonia

Dear Guillaume,

Thank you for your inquiry.

Indeed, there is a distribution notification obligation in Estonia and it is based on Medical Device Act § 26 (4):

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng.

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name, e-mail and the position in the company.  If there is a need for an account, please let me know.

The national distribution notification is separate from the EUDAMED registrations, and it remains in place even when EUDAMED is fully functional. The purpose of the distribution notification is to identify local distributors and the devices being distributed.

Please do not hesitate to contact me for further information or with any questions.

Good morning,

I have a client in Europe who has registered his medical device in the EUDAMED database, and who asks me if it is still necessary to register it with the competent authorities of EU countries.

Is it always necessary to register your device in Estonia?

If so, what is the procedure to follow, and until when will this procedure have to be followed?

Thank you in advance for your return.

Yours sincerely

Guillaume