Küsimused

Dear Marek Šturek,

Thank you for your enquiry.

National requirements for medical devices are established in the Medical Devices Act.

There is a distribution notification obligation for medical devices in Estonia and it is set out in the Medical Devices 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 (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) 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 State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time.

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,

• * EC Certificate,

• * Instructions for use in English,

• * A copy of the packaging / labelling of the device as a surface layout (for layusers one-to-one translation from the original 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. https://msa.sm.ee/ctrl/en/Mall/index/?

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. 

Please let us know if you require an account for EMDDB.

The labelling requirements for medical devices are set out in Medical Device Regulation (EU) 2017/745 and InVitro Medical Device Regulation (EU) 2017/746.

National language requirements are established in Article 16§(3) of the Medical Devices Act:

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.

It is possible to distribute a device intended for professional use with information in English; however, this should be agreed upon in advance between the user and the supplier of the device, as the professional user has the right to request that the information be provided in Estonian.

This right arises from §17 of the Language Act, which states that users have the right to receive information in Estonian from the trader regarding the characteristics and conditions of use of a product or service.

You can read more about the language and labelling requirement from the link below

https://ravimiamet.ee/en/medical-devices/medical-devices/labelling-language-requirements

Kind regards,

Maarika Ojala

Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

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