EUROPEAN COMMISSION
DIRECTORATE GENERAL for HEALTH and CONSUMERS
亡命千万里
Consumer Affairs
Health technology and Cosmetics
Note
The prent Guidelines are part of a t 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 rvices, 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 reprentatives of interest parties in the medical devices ctor.
CONTENTS
1
2
3
4
1. Introduction (3)
5
2. Scope (4)
6
3. References (4)
7
4. Definitions (6)
8
5. Circumstances where a post market clinical follow up study in indicated (8)
9
6. Elements of a post-market clinical follow up study (10)
10转移虚拟内存
7. The u of study data (12)选修课挂科
11
8 The role of the notified body in post-market clinical follow up (12)
12
13
14
Preface
15
This document is intended to be a guide for manufacturers and Notified Bodies on 16
how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil 17
Post-Market Surveillance (PMS) obligations according to Section 3.1 of Annex II, 18
Section 3 of Annex IV, Section 3 of Annex V, Section 3.1 of Annex VI or Section 4 19
of Annex VII of the Medical Devices Directive (93/42/EEC) and Section 3.1 of 20
Annex 2, Section 3 of Annex 4, Section 3.1 of Annex 5 of the Active Implantable 21
Medical Devices Directive (90/385/EEC). The Sections refer to requirements of 22
Annex X of Directive 93/42/EEC and Annex 7 of Directive 90/385/EEC, respectively.
薪酬管理
23
24
Attention is drawn to paragraph 8 of Article 15 of Directive 93/42/EEC which spells 25
out the provisions of Article 15 that are not applicable to clinical investigations
26
conducted using CE-marked devices within their intended u.
27
Similarly when PMCF studies are conducted using CE marked devices within their
28
intended u, the provisions of ction 2.3.5 of Annex X of Directive 93/42/EEC do 29
not apply. However, the provisions of Directive 93/42/EEC concerning information 30
and notification of incidents occurring following placing devices on the market are
31
fully applicable.
32
1. Introduction
33
34
While clinical evidence is an esntial element of the premarket conformity 35
asssment process to demonstrate conformity to Esntial Requirements, it is 36
important to recogni that there may be limitations to the clinical data available in 37
the pre-market pha. Such limitations may be due to the duration of pre-market 38
clinical investigations, the number of subjects and investigators involved in an 39
investigation, the relative heterogeneity of subjects and investigators and/or the 40
controlled tting of a clinical investigation versus the full range of clinical conditions 41
encountered in general medical practice.
42
43
A precondition for placing a product on the market is that conformity to the relevant
44
Esntial Requirements, including a favourable benefit/risk ratio, has been 45
demonstrated. The extent of the data that can be gathered in the pre-market pha 46
does not necessarily enable the manufacturer to detect rare complications or problems 47
that only become apparent after wide-spread or long term u of the device. As part of 48
the manufacturer’s quality system, an appropriate post-market surveillance plan is key 49
to identifying and investigating residual risks associated with the u of medical 50
devices placed on the market. The residual risks should be investigated and assd 51
in the post-market pha through systematic Post-Market Clinical Follow-up (PMCF) 52
study(ies).
53
54
Clinical data obtained from post-market surveillance and during PMCF studies by the 55
manufacturer are not intended to replace the pre-market data necessary to demonstrate 56
conformity with the provisions of the legislation. However, they are critical to update 57
the clinical evaluation throughout the life-cycle of the medical device and to ensure 58
the long term safety and performance of devices after their placing on the market.
59
60
PMCF studies are one of veral options available in post-market surveillance and 61
contribute to the risk management process.
62
63
64
65
66
2. Scope
67两个的英语
68
The objective of this document is to provide guidance on the appropriate u and 69
conduct of PMCF studies to address issues linked to residual risks. The intention is 70
not to impo new regulatory requirements.
71
72
PMCF studies are an important element to be considered in PMCF or PMS plans. The 73
principles for PMCF studies t out in this guidance are not intended to replace PMCF 74
or PMS plans. They are or may be applicable to PMCF studies conducted for other 75
purpos.
76
77
This document provides guidance in relation to:
78
拍手歌教案i)the circumstances where a PMCF study is indicated;
79
ii)the general principles of PMCF studies involving medical devices;
80
iii) the u of study data (for example to update instructions for u and labelling);
81
and
82
iv)the role of a notified body for medical devices in the asssment of PMCF plans 83
and of the results obtained from the plans as part of conformity asssment.
84
85
泸州方山风景区This document does not apply to in vitro diagnostic devices.
86
87
3. References
88
春分图片89
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as last 90
amended by Directive 2007/47/EC of the European Parliament and of the Council of 91
5 September 2007.
92
93
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of 94
the Member States relating to active implantable medical devices last amended by
95
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 96
2007.
97
98
99
100
