MEDDEV 2.12-2 : REV 2012
Current
The latest, up-to-date edition.
POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Hardcopy
English
01-01-2012
1. Introduction
2. Scope
3. References
4. Definitions
5. Circumstances where a post market clinical follow
up study in indicated
6. Elements of a post-market clinical follow up study
7. The use of study data
8. The role of the notified body in post-market clinical
follow up
Gives guidance on the appropriate use and conduct of PMCF studies to address issues linked to residual risks.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Guide
|
| Pages |
14
|
| PublisherName |
European Union
|
| Status |
Current
|
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| 14/30302761 DC : 0 | BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS) |
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| BIP 0113:2012 | Guide to European medical device trials and BS EN ISO 14155 |
| ISO 11249:2018 | Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies |
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| 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 |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
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