Vastuskiri

Dear Ruta,

Thank you for your enquiry concerning medical device registration.

The main EU legislation that you need to comply with in order to distribute medical devices in Estonia is EU regulation 2017/745 (MDR). You will find the general obligations of both manufacturers and distributors stated in articles 11 and 14 respectively of MDR. Annex IV of MDR describes the EU Declaration of Conformity that you need to provide during the registration process. Please familiarize yourself thoroughly with MDR as all the documents that you provide during the registration process need to comply with MDR.

The main national regulations that apply are Estonian Medical Devices Act (MDA) and Estonian Language Act (LA).

According to §26 (4) of MDA:

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 Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

MDA §16 (3) states:

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.

But as the Estonian LA also applies you have to also follow its requirements and §17 regulates the right of consumers to information in Estonian:

 (1) Consumers of goods and services have the right to receive information and servicing in Estonian in compliance with the Consumer Protection Act.

 (2) A person who is not a consumer for the purposes of clause 1 of subsection 1 of § 2 of the Consumer Protection Act has the right to receive information from the trader about the product or service features and terms and conditions of use in Estonian.

In summary you have to comply with all the general regulations and you have to determine who is the user of your product. In most cases you have to be prepared to present the user with a user manual in Estonian language.

To register your MD-s, you need to submit an application through Estonian Medical Devices and Appliances Database (EMDDB). This can be done free of charge. For actors outside of Estonia we can make an account manually, so it is possible to log into the database with a 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 us know.

Documents that need to be supplied with the notifications of medical devices are following:

• Declaration of conformity (as described in annex IV of MDR),

• EC Cerificate(s) if applicable,

• instructions for use (in English and Estonian) and

• a copy of the labelling or packaging of the device.

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“. It is a step-by-step guide on how to carry out the notification process successfully in the database.

If you have any further questions, please don’t hesitate to contact us again.

Yours sincerely

Janne Aule

Chief Specialist

Department of Medical Devices

+37258668664

[email protected]

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Dear Terviseamet Team, 

We would like to enter our products to Estonian market.  

Medical devices and orthopedics.

Please provide all information needed to make registration of the products.

Kind regards, 

Ruta Pukanase - CEO

 UAB JUDU

Gedimino g. 34, Kaunas, 44320

www.medinet.lt