Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

MEDDEV 2.12-2 : REV 2012

Current
Current

The latest, up-to-date edition.

POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Available format(s)

Hardcopy

Language(s)

English

Published date

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

AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
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
AAMI ISO 14155 : 2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
14/30302761 DC : 0 BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
MEDDEV 2.7-4:2010 GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
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 2.7-2 : 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
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

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 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

View more information
Free

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more