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Regulation (EU) 2017/745 : 2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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 (TEXT WITH EEA RELEVANCE.)
Available format(s)

Hardcopy

Superseded date

12-21-2022

Language(s)

English

Published date

04-05-2017

Describes rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Pertains to clinical investigations concerning such medical devices and accessories conducted in the Union.

DevelopmentNote
Supersedes 93/42/EEC. (08/2017) Supersedes 90/385/EEC, 2001/104/EC & 2007/47/EC which remain valid until 25/05/2020. (09/2017)
DocumentType
Standard
Pages
228
PublisherName
European Union
Status
Superseded
SupersededBy
Supersedes

ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice

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