Kiri

Dear Marcel,

While EUDAMED is not yet operational and mandatory according to MDR, class I devices can be placed on the market through the national Medical Devices and Appliances Database, as outlined in § 41² of the Medical Device Act:

Until the implementation date of the obligations set out in points d and e of subsection 3 of Article 122 of Regulation (EU) 2017/745 and in points a and f of subsection 3 of Article 113 of Regulation (EU) 2017/746 of the European Parliament and of the Council related with the European database on medical devices, the exchange of information with the Health Board and the transmission of data to the Health Board takes place according to the wording of the Medical Devices Act in force prior to entry into force of this wording.

The previous version of the act https://www.riigiteataja.ee/en/eli/ee/503022022001/consolide

with the relevant section being § 26 (1):

Any person who places a class I medical device, custom-made medical device, system of medical devices, procedure pack or in vitro diagnostic medical device on the market in Estonia, shall notify, at least ten days before the medical device is placed on the market, the Health Board of the intention to place the medical device on the market and of any significant alterations of the medical device.

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/) and is free of charge.

The required documents for device notification include: Declaration of conformity, instructions for use, and a copy of the labeling or packaging.

Please refer to the short guide available on the Estonian Medical Device Database homepage under "Forms" for step-by-step instructions on successful notification.

There is no separate fixed template for notification; instead, general data is required, and its elements can be viewed by opening any device already notified in the database.

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. 

Additionally, language requirements for medical devices in Estonia can be found also in Medical Devices Act § 16 (3) and it is written as following:

The manufacturer, relying on risk analysis, ascertains the information necessary for the safe use of a device for the intended purpose, and the information related with a medical device placed on the market, made available on the market, distributed and put into service in Estonia must be presented:

1) in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;

2) in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;

3) in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.

Please familiarize yourself comprehensively with the national Medical Devices Act so that you are up to date with the national requirements.

 Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Hello,

I have a question and hope you can help me.

The following scenario: I am a manufacturer of Class I medical devices and am based in Germany and have registered my products in DMDIS Germany. Also I am already registered as a manufacturer in Eudamed but the products are not because I have transition time. What do I have to do to sell the products in Estonia? Do I have to register them in Estonia or is the German registration sufficient? What do I have to do to sell my products in Estonia?

Thank you and best regards :)

Marcel Vila Wagner

Marcel Vila Wagner

Executive Department Manager Quality Management
Quality Management

CRS medical GmbH
Loherstrasse 6
35614 Asslar

T: +49 - 6441 / 38 331 - 195
M: +49 - 151 / 18 513 771

[email protected]

www.crs-medical.com


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