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EUROPEAN COMMISSION
DIRECTORATE GENERAL for HEALTH and CONSUMERS
Consumer Affairs
Health technology and Cosmetics
MEDDEV 2.12/2 rev2
January 2012
GUIDELINES ON MEDICAL DEVICES
POST MARKET CLINICAL FOLLOW-UP STUDIES
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Note
The present Guidelines are part of a set of Guidelines relating to questions of
application of EC-Directives on medical Devices. They are legally not binding. The
Guidelines have been carefully drafted through a process of intensive consultation of
the various interest parties (competent authorities, Commission services, industries,
other interested parties) during which intermediate drafts where circulated and
comments were taken up in the document. Therefore, this document reflects positions
taken by representatives of interest parties in the medical devices sector.
1 CONTENTS
2
3
4
5 1. Introduction 3
6 2. Scope 4
7 3. References 4
8 4. Definitions 6
9 5. Circumstances where a post market clinical follow up study in indicated 8
10 6. Elements of a post-market clinical follow up study 10
11 7. The use of study data 12
12 8 The role of the notified body in post-market clinical follow up 12
13
14
15 Preface
16 This document is intended to be a guide for manufacturers and Notified Bodies on
17 how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil
18 Post-Market Surveillance (PMS) obligations according to Section 3.1 of Annex II,
19 Section 3 of Annex IV, Section 3 of Annex V, Section 3.1 of Annex VI or Section 4
20 of Ann
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