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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Language(s)
English
Published date
05-04-2017
Publisher
Superseded date
21-12-2022
Superseded by
Free
Excluding VAT
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Superseded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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