Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46

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 46
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Investigational device, Definition, Clinical investigation
Comment	Definition of investigational device

Content

(46) ‘investigational device’ means a device that is assessed in a clinical investigation;