Küsimused

Dear Karl Kalev Türk,

thank you for your kind and clear reply.

Just one more clarification/suggestion.

I understand Depofarma can notify itself as manufacturer and then medical devices, then, selected distributor can bound itself to manufacturer as distributor, accordingly. Is it correct?

Kind regards,

Dear Laura Righetto,

Thank you for your enquiry.

Indeed, there is a distribution notification obligation for medical devices 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.  In the case of the Estonian distributor, we kindly ask them to use secure authentication services to log into the database.

There are no fees associated with the fulfillment of the distributor notification or activities.

We also recommend consulting the short user guide for using the Estonian Medical Device Database under “Forms” on the database homepage, as it contains more detailed information on which documents and information need to be provided with the notification.

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

[email protected] | [email protected] 

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To the kind attention of Department of Medical Devices/Estonian State Agency of Medicines,

I am Laura Righetto for the Italian Company Depofarma.

Depofarma is interested in marketing its medical devices in Estonia with the support of a selected local distributor. Medical devices are class IIa approved by Notified Body, already registered and marketed in Italy.

In order to understand if notification is required in Estonia, I have read the guidelines, however, something is still not clear for me, would you mind helping me clarifying the following questions:

A medical device already marketed in an EU Member State has to be notified and the fee has to be paid?

If yes, who has to do this?  Manufacturer (Depofarma) or Distributor?

Could you clarify all steps for notification, if required?

I have seen an Estonian ID is necessary, how can we manage this?

Thank you for your attention, your kind reply would be really appreciated.

Laura Righetto

Ufficio/Office: 041-4574044 interno 202

DEPOFARMA S.p.A.

sede legale/head office : Via  Terragliol, 67 - 31022 Preganziol (TV)

sede operativa/operational headquarters: Via Tintoretto, 9/a - 11 int.6 e 7- 31021 Mogliano Veneto (TV)

REA nr. TV 100.717 - CF e PIVA/VAT NUMBER: 00225490267 - Capitale Sociale/Share Capital  € 120.000 i.v.

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