Kiri

Saatja: Sinwoo Kang 강신우 <swkang@lutronic.com>
Saatmisaeg: teisipäev, 27. august 2024 06:21
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: Re: Inquiry regarding importers and distributors in MDR

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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

maarika.ojala@terviseamet.ee

Republic of Estonia

Health Board

+372 794 3500

info@terviseamet.ee

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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