Vastuskiri

Saatja: Miki Melech <miki.m@arazygroup.com>
Saatmisaeg: kolmapäev, 19. oktoober 2022 13:10
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: Re: Notification of Class IIb Software application

Dear Miki,

 

Thank you for your enquiry.

 

Indeed, there is a mandatory distribution notification requirement in Estonian and it is based on Medical Devices Act § 26 (3¹) (https://www.riigiteataja.ee/en/eli/ee/524052016001/consolide/current) which says:

Any person who distributes for the first time in Estonia or puts into professional service a class II a, II b or III medical device or an active implantable medical device shall notify the Health Board thereof within ten days after distribution for the first time or putting into professional service of the device.

               

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

 

The notification is free of charge. We recommend companies to find an Estonian citizen who can log into the database (by mobile-ID or by ID-card) and who will register their represented company’s medical devices into our database. It is because some of the information is needed in Estonian.

 

If needed 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, e-mail and the position in the company.

 

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use and copy of the labelling or packaging.

 

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

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

 

Terviseamet | Health Board +372 794 3500 info@terviseamet.ee www.terviseamet.ee Paldiski mnt 81, 10614 Tallinn

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Saatja: Miki Melech <miki.m@arazygroup.com>
Saatmisaeg: reede, 7. oktoober 2022 10:57
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: Notification of Class IIb Software application

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

Dear Sir / Madam

Our client approached us to assist with the medical device notification in Estonia

 

They have a Class IIb Software application, CE approved by TUV Rheinland. due to the fact it is a SW application, they do not have a distributor in Estonia. 

The manufacturer is not located in the EU but has an EU AR (in the Netherlands) and importers located in 2 EU countries (not in Estonia)

the device is for home use only and they do not have a domestic distributor or importer in Estonia. 

all Economic operators already registered in EUDAMED and have SRN number

 

Is the device subject to any device notification in Estonia?

 

will appreciate your reply

 

Kind regards

Miki

 

 Miki Melech

Head of EU Division / Senior Regulatory Expert

Email: miki.m@arazygroup.com | Skype: michalmel | Mobile: +972.50.884.1024

Web: http://arazygroup.com | Office: Manof, Israel | Phone: +972.4.994.7880