第三章 MEDDEV 2.12-2 rev2 2012 PMS.pdf

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