Vastuskiri

Dear Alisa,

Thank you for your letter concerning class I MD registration in Estonia.

As your devices are class I MD registration in the Estonian Medical Devices and Appliances Database is voluntary, but you are still welcome to register your devices. Even if you decide to not register your devices you still need to comply with the language requirements that apply in Estonia.

The main legislations you need to comply with in order to distribute class I MD-s in Estonia are EU regulation 2017/745 (MDR), Estonian Medical Devices Act (MDA) and Estonian Language Act (LA).

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. Since your query concerns class I medical devices, you are not required to provide a certificate from a notified body except when you are talking about devices that are placed on the market in sterile condition, devices with a measuring function or reusable surgical instruments in which cases you do need to involve a notified body and provide us with a certificate (MDR Article 52 (7)).

The main national regulations that apply are MDA and 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), instructions for use (in English and Estonian) and 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