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| Dokumendiregister | Terviseamet |
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| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
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| Juurdepääsupiirang | |
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| Saabumis/saatmisviis | Lytronic |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Sinwoo Kang 강신우 <[email protected]>
Sent: Tue, 27 Aug 2024 03:20:54 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: Re: Inquiry regarding importers and distributors in MDR
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
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Whether the IMPORTER within the EU who purchased our product can sell the product directly to the END USER without a separate DISTRIBUTOR,
*Supply chain
Manufacturer > Importer > End user
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And whether the END USER is considered as a distributor in this case.
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보낸 날짜: 2024년 8월 26일 월요일 21:52
받는 사람: Sinwoo Kang 강신우 <[email protected]>
제목: Vs: Inquiry regarding importers and distributors in MDR
Dear Sinwoo Kang,
Thank you for your enquiry.
The distributor is not considered the end user, for clarification please see the information below.
According to the Medical Device Regulation (EU) 2017/745 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20230320
please review the definitions of importer and distributor Article 2.
(33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
(34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
Please also refer to the following definitions from Medical Device Regulation (EU) 2017/745 Article 2.
(28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
(29) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
(37) ‘user’ means any healthcare professional or lay person who uses a device;
(38) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
You also might find useful the following Blue Guide (the implementation of EU product rules 2022).
The Guide is meant for a better understanding of EU product rules and facilitation of their uniform application across sectors throughout the Single Market. The Blue Guide is a non-binding instrument.
You can find it at the link below, which defines the end user:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC
— The end user is any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities.
Kind regards,
Maarika Ojala
Chief Specialist
Department of Medical Devices
+372 5400 4028
Republic of Estonia
Health Board
+372 794 3500
www.terviseamet.ee
Paldiski mnt 81, 10614 Tallinn
Estonia
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Saatja: Sinwoo Kang
강신우 <[email protected]>
Saatmisaeg: esmaspäev, 26. august 2024 06:38
Koopia: Daeho Choi 최대호 <[email protected]>; Chidae Park
박치대 <[email protected]>; Jungmi Lee
이정미 <[email protected]>; Heesun Kwon
권희선 <[email protected]>; Jiwon Jeong
정지원 <[email protected]>
Teema: Inquiry regarding importers and distributors in MDR
Hello.
I'm Sinwoo Kang, a QA person at Lutronic, a Korean medical device manufacturer.
I am sending this email because I have a question about importers and distributors in MDR.
(I sent the same question to EU, but they replied that I have to check with each competent authority.)
MDR defines Importer and Distributor as follow;
a. Importer : any natural or legal person established within the Union that places a device from a third country on the Union market;
b. Distributor : any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service
I am sending this email to clarify the following in order to determine our business model.
If an importer sells a product directly to an end user, is the end user considered a distributor? (Not selling to patients, but using directly)
I will wait for your reply.
Thank you in advance.
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NOTICE : This email is for the sole use of the intended recipient(s). Unless otherwise indicated, it contains confidential and/or proprietary information. If you have received this message in error, please notify the sender of the error and delete the message including its attachment.
NOTICE : This email is for the sole use of the intended recipient(s). Unless otherwise indicated, it contains confidential and/or proprietary information. If you have received this message in error, please notify the sender of the error and delete the message including its attachment.
