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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45: Difference between revisions

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Paragraph 45
Paragraph 45
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|tags_display=[[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00155-Med-Med|Medical device]]
 
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! colspan="2" class="gplx-infobox-header" | Reference Details
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| Module 1 — Unit 1.2.2
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! Document part
| Article 2
Paragraph 45
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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== Content ==
Definitions


(45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
(45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
}}

Revision as of 12:54, 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 — Unit 1.2.2
Scope MD
Document part Article 2

Paragraph 45

Language EN
Original entry by Florian Adragna
Contributors
Tags Clinical investigation, Definition, Medical device

Content

Definitions

(45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

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