Vastuskiri

Dear Kristin,

Thank You for Your e-mail.

All national provisions supplementing the MDR are described in the  Estonian Medical Devices Act (MDA) and its implementing acts.

Prior to distributing Your device on the market of Estonia, the manufacturer must place the devices on the market in accordance with the requirements of the MDR. After that, distribution notification is mandatory for devices belonging to classes IIa, IIb or III according to the MDA § 26 (4):

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

Notification of class I medical device distribution is considered voluntary.

The distribution notification can be made through Estonian Medical Device Database (EMDDB). This procedure is free of charge. Please note that for actors outside of Estonia, the account for the notification in the EMDDB is made manually by the Health Board. For creating an account, please provide us the contact person’s full name, e-mail and the position in the company. Additionally, the access to the database is limited to the users, who reside outside of Estonia. To resolve this, please contact [email protected] with a request to access the database an provide your IP address. They will white-list Your IP, which should give You the access to the database. Further EMDDB instructions for use are found on the database homepage under „Forms“.

For any further questions, please do not hesitate to contact us again.

Dear Madam(s) / Sir(s),

I hope this email finds you well.

I am reaching out to you with regards to registration requirements for distributors of medical devices per EU MDR.

We seek guidance on the following question:

Would a company located outside Estonia (but in the EU) be required to register as a distributor of medical devices in Estonia in addition to their registration in another EU country?

The scenario would be as follows: a medical device already on the EU market (but outside Estonia) will be distributed to a healthcare facility for a defined timeframe within a drug clinical trial. After the trial ends, the device will be shipped back. The device is CE marked and not in scope of the clinical trial or clinical investigation, but only used for collection of clinical data to support trial endpoints.

In this scenario, would the distributor located in another EU country (and already registered in that country) be required to register in Estonia as well?

Thank you very much in advance for your kind feedback and response.

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