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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14: Difference between revisions

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 1 β€” Unit 1.2.2
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! Document part
| Article 2
Paragraph 14
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! Language
| EN
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== Content ==
(14) β€˜instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;

Latest revision as of 13:49, 16 July 2026



Document information
Reference EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
Validity area EU
Scope(s) MD
Document name Regulation (EU) 2017/745 - Medical Device Regulation
Version / Revision 20-Mar-2023
Status Current
Document type Legal act
Language(s) EN
Description REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 β€” Unit 1.2.2
Scope MD
Document part Article 2

Paragraph 14

Language EN
Original entry by Florian Adragna
Contributors
Tags Instructions for use, Definition

Content

(14) β€˜instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;