Vastuskiri

Dear Travis,

Thank you for your additional question, and apologies for the delayed response. I was on a rather long vacation.

Indeed, if you as a manufacturer are directly distributing your devices in Estonia, you are also eligible to notify us through our national database.

As I mentioned in my previous letter, if you need an account in the database to submit notifications, please let me know.

Dear Karl,

I have another question for you about the notification of the distributors in Estonia.

With your kind email it's clear that the distributors need to make a notification before selling medical device. But If an Italian Manufacturer wants to sell Medical Devices in Estonia's market what are the rules to follow? Does he need to make the notification in the same Database or there is another procedure/Database?

Thank you so much, best regards

Dear Marianna,

 

Thank you for your enquiry.

 

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 and e-mail.  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.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

 

Republic of Estonia Terviseamet | Health Board +372 794 3500 info@terviseamet.ee www.terviseamet.ee Paldiski mnt 81, 10614 Tallinn Estonia

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

 

Saatja: qualita2@newancorvis.eu <qualita2@newancorvis.eu>
Saatmisaeg: kolmapäev, 5. juuni 2024 09:27
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>; Passarini, Samuela (New Ancorvis) <qualita@newancorvis.eu>
Teema: Estonia: Procedure to sell Medical Devices

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

To whom it may concern,

I'm kindly asking to know the right procedure in order to sell Medical Devices in your National Market.

Before Eudamed will be completely operative, the rules to sell Medical Devices in all European contries are different and every Nation has his own rules (For examples: in some nations it's correct just to make a right registration of MDs in Eudamed platform; in others to follow the correct procedure it's necessary send a Declaration with all the categories of products the Factory is going to sell in the specific National Market; some States want an individual registration of each Medical Device or sometimes the rules are different from a Class to risk to an other).

We specify that:

- New Ancorvis s.r.l is an Italian Factory that produces and certifies class I - IIa - IIb Medical Devices

- New Ancorvis has a correct registration as Medical Device Manufacture in Eudamed

- New Ancorvis has a correct registration of his products in Italian Medical device database

- New Ancorvis Factory has MDR certification with the notify body ICIM 0425

Looking forward your response, thank you for your kind collaboration.

Best Regards 

--

Marianna Govoni

Assistente Assicurazione Qualità - Regulatory Affairs

Via dell'Industria,15
40012 Bargellino- Calderara di Reno (BO) -Italy

Tel.:+39 051 6463070 . INT.7
Fax: +39 051 6463076

E-mail: qualita@newancorvis.eu

Website: www.newancorvis.eu   

P.I./ C.F.: 01878171204
SDI: 5RUO82D

 

             

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