Saatja: Meditsiiniseadmed (Medical Devices) </o=Sotsiaalministeerium/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=user2eb434cb>
Saaja: '
[email protected]', Meditsiiniseadmed (Medical Devices)
Teema: Vs: Notified Body
Dear Truong Pham My Linh,
Thank you for your request.
All essential requirements are provided in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. Also please see additional guidances here:
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec12 Please note that the guidance documents on this page are not legally binding.
Very soon the Estonian Medical Devices Act <https://www.riigiteataja.ee/akt/103012022015?leiaKehtiv> (MDA) will be updated and with that some fees will be introduced. The changes in the MDA can be viewed here (these documents are in Estonian):
https://www.riigikogu.ee/tegevus/eelnoud/eelnou/8173d025-6c81-4f51-8fe4-a94801ecada3/Meditsiiniseadme%20seaduse%20muutmise%20ja%20sellega%20seonduvalt%20teiste%20seaduste%20muutmise%20seadus
Please be informed that according to the updated MDA all submitted documents are expected to be in Estonian or in English.
All documents and application are to be submitted to the Estonian designated authority Health Board
[email protected] <mailto:
[email protected]>
If you have additional questions, please do not hesitate to contact us.
Best regards,
Kristina Kübar
Chief Specialist
Department of Medical Devices
Phone +372 5330 5236
[email protected] |
[email protected]
Republic of Estonia
Health Board
+372 794 3500
[email protected] <mailto:
[email protected]>
www.terviseamet.ee <http://www.terviseamet.ee/>
Paldiski mnt 81, 10614 Tallinn
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Saatja: Riigikantselei <
[email protected]>
Saatmisaeg: neljapäev, 15. detsember 2022 10:56
Adressaat: TA Info <
[email protected]>
Koopia:
[email protected]
Teema: FW: Notified Body
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From: Mỹ Linh Trương Phạm <
[email protected] <mailto:
[email protected]> >
Sent: Thursday, December 15, 2022 10:46 AM
To: Riigikantselei <
[email protected] <mailto:
[email protected]> >
Subject: Notified Body
Dear Health Board Terviseamet,
We are Brilitas Pharmaceuticals EU OÜ, with registration code is 16618699.
Brilitas plans to become a Notified Body that conducts assessment of the conformity of medical devices before it is put on the market. However, this right is granted by the competent authority.
Brilitas would like to know the government regulations on eligibility and application process to be designated a Notified Body.
We look forward to response from the Health Board Terviseamet.
In Peace and Happiness,
Best regards,
Lin.
Truong Pham My Linh (Ms.)
Legal Administration
Brilitas Pharmaceuticals Joint Stock Company
Phone: (+084) 902 850 112
Email:
[email protected] <mailto:
[email protected]>