Vastuskiri

Dear Alina,

Thank you for your inquiry.

I would like to provide you with the link to the current version of the Medical Device Act. The one mentioned in your letter is actually an older version that was in force until 31.01.2022.

Compared to the older version, the distribution notification requirement has also changed. It can now be found in § 26 (4) and is worded as follows:

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.

The notification process does not require an importer or distributor established in Estonia to notify us. It is quite common for the manufacturer, in the case of direct distribution, to handle the notification itself.

The distribution notification can be submitted through the Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

In the case of a non-Estonian user unable to use the national secure authentication method for e-services, we can manually create an account. This allows access to the database using a username and password. To create an account, we need the full name and email of a contact person. The account itself is personal (not for the company). The person then adds the company to the database and links themselves to it.

Additionally, there is a short guide for using the Estonian Medical Device Database available on the database homepage under „Forms“. It provides a step-by-step guide on how to successfully submit notifications in the database. It may be worth taking a look to understand the process overall.

If you have any further questions, feel free to ask.