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MEDDEV 2.7-4:2010

Current
Current

The latest, up-to-date edition.

GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Available format(s)

Hardcopy

Language(s)

English

Published date

12-01-2010

Publisher

European Union

1 Introduction
2 Scope
3 References
4 Definitions
5 General Principles When Considering the Need
  for a Clinical Investigation
6 General Principles of Clinical Investigation Design
7 Ethical Considerations for Clinical Investigations

Gives guidance in relation to: - when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Requirements; and - the general principles of clinical investigations involving medical devices.

DevelopmentNote
Available for free download. (01/2017)
DocumentType
Standard
Pages
10
PublisherName
European Union
Status
Current

MEDDEV 2.7-2 : REV 2 GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC

MEDDEV 2.7-1 : REV 4 2016 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC
MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
MEDDEV 2.7-2 : REV 2 GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

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Hardcopy - English
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