Kiri

Dear Olena,

Please find the answers to your questions from here:

According on Medical Device Act § 26 (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 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.

According to the Blue Guide (Implementing the EU Product Regulation 2022), which is not a non-binding legal instrument, but where you can find information on actors in the product supply chain and their obligations.

This information can be found at the following link:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC

(„THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS“)

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Kristina,

Is my understanding correct that if the Legal Manufacturer notifies the Health Board about the medical devices directly, the distributor does not need to perform the notification?

My client does not have a distributor in Estonia and is therefore concerned about whether having a distributor is mandatory.

Best regards,

Olena

Dear Olena,

Thank you for your enquiry.

Indeed, there is a distribution notification obligation in Estonia and it is based on Medical Device Act § 26 (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 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.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng

If this company does not have an entity in Estonia, for actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name and e-mail.  If there is a need for an account, please contact Karl Kalev Türk [email protected]

The national distribution notification is separate from the EUDAMED registrations, and it remains in place even when EUDAMED is fully functional. The purpose of the distribution notification is to identify local distributors and the devices being distributed.

Please do not hesitate to contact me for further information or with any questions.

Dear Madam/Sir,

I represent Qserve, a consulting company. One of our clients is preparing to launch a CE-marked medical devices (class IIa/IIb) in the EU Member States, including Estonia.

The Legal Manufacturer is based in the USA, with an EU Authorized Representative in Ireland and an importer facility in the Netherlands. This company does not have an entity in Estonia. The products will be shipped directly to the pharmacies from the importer’s warehouse in the Netherlands.

Given this setup, I have a question regarding distributor registration and device notification in Estonia. Is it mandatory to have an entity established in Estonia to assume the role of Distributor in order to perform device notification?

If not, who shall perform notification of the devices, Legal Manufacturer?

Thank you very much for your response in advance!

Best regards,

Olena