MEDDEV 2.7-4:2010
Current
The latest, up-to-date edition.
GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Hardcopy
English
01-12-2010
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
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| 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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