Vastuskiri

Dear Ms. Lindeberg

Thank You for Your inquiry.

Estonian Medical Devices Act § 26 (4) states the following:

“(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.“

The Health Board can be notified via Estonian Medical Device Database (EMDDB).

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, do not hesitate to contact us again.

All the best,

Dear Estonia State Agency of Medicines,

Does Sobi AB located in Stockholm Sweden has to register with ‘Medical devices and appliances database’ as Distributor according to EU MDR (745/2017) when distributing CE-marked medical device on the Estonian market?

Thank you very much for your support and guidance in advance.

Best regards,

Alexandra Lindeberg, M.Sc. Pharm

Medical Affairs Manager Nordics & Baltics

_____________________________

Switch board +46 8 697 2000, Mobile +46 720832510
[email protected]
Swedish Orphan Biovitrum AB
SE-112 76 Stockholm, Sweden
Visitors: Tomtebodavägen 23A, Solna
www.sobi.com
www.sobi.se

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