Kiri

Dokumendiregister Terviseamet
Viit 11.1-2/24/2174-1
Registreeritud 23.02.2024
Sünkroonitud 26.03.2024
Liik Sissetulev dokument
Funktsioon 11.1 Turustamise järgne järelevalve (post-marketing surveillance)
Sari 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks
Toimik 11.1-2/2024
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat eResearchTechnology GmbH
Saabumis/saatmisviis eResearchTechnology GmbH
Vastutaja Merili Saar (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

Registration requirements medical device distributor.msg

From: "Feld, Kristin" <Kristin.Feld@Clario.Com>
Sent: Mon, 19 Feb 2024 14:46:28 +0000
To: "mso@terviseamet.ee" <mso@terviseamet.ee>
Subject: Registration requirements medical device distributor

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


 

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.

 

--

Mit freundlichen Grüßen / With kind regards

 

Kristin Feld (she/her)
Manager Regulatory Affairs, Quality Management & Regulatory Compliance


eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Office +49-9305-7206377


clario.com


 


Disclosures in accordance with Section 37a (1) HGB: eResearchTechnology GmbH | Sieboldstraße 3 | 97230 Estenfeld | Registry court: Amtsgericht Würzburg | Register number: HRB 10688 | Authorized representatives/Managing directors: Daniel Braem, Christopher Charles Fikry, Hans Joachim Schülke, Wolfgang Messner << --Confidentiality Notice: This e-mail transmission may contain restricted, confidential, and/or legally privileged information that is intended only for the individual(s) or entity(ies) named in the e-mail address(es), or the individual(s) or entity(ies) reasonably understood to be the intended recipient(s) via the content or context of the transmission. If you are not the intended recipient, any disclosure, copying, distribution, or reliance upon the contents of this e-mail is by you is prohibited. If you have received this transmission in error, please reply directly to the sender to notify them of their error then immediately delete the message.--

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