Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/8574-6 |
| Registreeritud | 27.08.2024 |
| Sünkroonitud | 28.08.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Lutronic |
| Saabumis/saatmisviis | Lutronic |
| Vastutaja | Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Tue, 27 Aug 2024 05:30:03 +0000
To: Sinwoo Kang 강신우 <[email protected]>; "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: Vs: Inquiry regarding importers and distributors in MDR
Dear Sinwoo Kang,
We have answered your questions as well as provided you with relevant sources for the topic.
Regretfully, there is nothing further we can add.
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.
Saatja: Sinwoo Kang 강신우 <[email protected]>
Saatmisaeg: teisipäev, 27. august 2024 08:23
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: Inquiry regarding importers and distributors in MDR
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Piret Põiklik ,
Thank you for your reply.
I think I was too brief in my question, so I'll ask again with some additional explanation.
- Can an importer who purchases products from outside the EU sell the products directly to the end user without a separate distributor?
*Supply Chain
Manufacturer > Importer > End User
- And in this case, is the end user considered a distributor?
Could you check again and reply?
Thank you.
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보낸 사람: Meditsiiniseadmed (Medical Devices) <[email protected]>
보낸 날짜: 2024년 8월 27일 화요일 14:01
받는 사람: Sinwoo Kang 강신우 <[email protected]>; Meditsiiniseadmed (Medical Devices) <[email protected]>
제목: Vs: Inquiry regarding importers and distributors in MDR
Dear Sinwoo Kang,
We are not aware of any such limitation that you appear to associate with the role of the importer.
The end user is a separate role from the distributor. They could theoretically be applied to the same person only if that person actually distributes the devices in addition to using them.
Best regards
Piret Põiklik
Head of Department
Department of Medical Devices
Phone +372 5853 3610
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.
Saatja: Sinwoo Kang 강신우 <[email protected]>
Saatmisaeg: teisipäev, 27. august 2024 06:21
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: Inquiry regarding importers and distributors in MDR
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Maarika Ojala,
Thank you very much for your answer.
I have confirmed the part you explained, and I would like to ask additional questions to clarify the part I wanted to confirm.
- 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
- And whether the END USER is considered as a distributor in this case.
I know you are busy, but please check again.
Thank you.
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보낸 사람: Meditsiiniseadmed (Medical Devices) <[email protected]>
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
Paldiski mnt 81, 10614 Tallinn
Estonia
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
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.
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.
