Ref. Ares(2015)2067487 - 18/05/2015 EUROPEAN COMMISSION
DIRECTORATE GENERAL for HEALTH and CONSUMERS
Consumer Affairs
Cosmetics and Medical Devices
MEDDEV 2.7/4
December 2010
GUIDELINES ON MEDICAL DEVICES
GUIDELINES ON CLINICAL INVESTIGATION:
A GUIDE FOR MANUFACTURERS AND NOTIFIED
BODIES
Note
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The prent Guidelines are part of a t of Guidelines relating to questions of application of EC-
灵性课程
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,
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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 Introduction (3)
2 Scope (3)
3 References (4)
4 Definitions (5)
5 General Principles When Considering the Need for a Clinical Investigation (6)
6 General Principles of Clinical Investigation Design (7)
7 Ethical Considerations for Clinical Investigations (10)
1 Introduction
The guidelines are bad on the guidance document SG5/N3:2010 of the Global Harmonization Task Force. They are adapted to the requirements on clinical investigations laid out in annex 7 of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC. The clinical investigations shall be performed as described in the annexes.
They reflect the connsus view of the various interested parties with regard to clinical investigations under the above-mentioned medical devices directives.
What is a clinical investigation?
A clinical investigation is defined as “any systematic investigation or study in or on one or more human subjects, undertaken to asss the safety and/or performance of a medical device.” (SG5/N1:2007).
The undertaking of a clinical investigation is a scientific process that reprents one method of generating clinical data.
What is the objective of a clinical investigation?
The objective of a clinical investigation is to asss the safety and clinical performance of the device in question and evaluate whether the device is suitable for the purpo(s) and the population(s) for which it is intended (EN ISO 14155-1:2009).
How is a clinical investigation conducted?
EN ISO 14155-1:2009 Clinical Investigation of Medical Devices for Human Subjects - General Requirements details the general requirements for the conduct of clinical investigations and EN ISO 14155-2:2009 Clinical Investigation of Medical Devices for Human Subjects - Clinical Investigation Plan contains detailed information about the procedure and contents of a clinical investigation plan.
Clinical investigations must take into account scientific principles underlying the collection of clinical data along with accepted ethical standards surrounding the u of human subjects. The clinical investigation objectives and design should be documented in a clinical investigation plan.
2 Scope
The primary purpo of this document is to provide guidance in relation to:
• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Esntial Requirements; and
• the general principles of clinical investigations involving medical devices.
Given the wide diversity of medical devices and their associated risks, this document is not intended to provide comprehensive guidance for clinical investigations of specific medical devices.
The guidance contained within this document is intended to apply to medical devices generally and to combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the u of Clinical Investigations to support clinical evaluation and a conformity asssment procedure. Some aspects
of this document may apply to studies conducted following commercial relea of a device. A parate guidance document specifically address post-market clinical follow-up (MEDDEV 2.12/2: Clinical Evaluation - Post Market Clinical Follow-up).
3 References
Directive 90/385/EEC, as amended by Directive 2007/47/EC
Directive 93/42/EEC, as amended by Directive 2007/47/EC
Interpretative Documents
MEDDEV 2.7.1 Rev. 3; December 2009
Clinical Evaluation: A Guide for Manufacturers and Notified
Bodies
MEDDEV 2.7.1, Appendix 1; December 2008
Evaluation of Clinical Data – A Guide for Manufacturers and
Notified Bodies – Appendix 1: Clinical Evaluation of Coronary
Stents
MEDDEV 2.7.2; December 2008
目录 英文
Guide for Competent Authorities in Making an Asssment of
Clinical Investigations Notification
MEDDEV 2.12/2; May 2004hydrogen
Clinical Evaluation - Post Market Clinical Follow-up
thorneGHTF final documents
SG5/N1:2007 Clinical Evidence – Key definitions and Concepts
SG5/N2:2007 Clinical Evaluation
Harmonized/International standardsdsl
EN ISO 14155-1: 2009
Clinical investigation of medical devices for human subjects – Part
1 General requirements
comfortable是什么意思EN ISO 14155-2: 2009
Clinical investigation of medical devices for human subjects – Part
2 Clinical investigation plans
EN ISO 14971: 2009
Application of risk management to medical devices
Other References
World Medical Association – Declaration of Helsinki - Ethical
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principles for medical rearch involving human subjects
4 Definitions
Clinical Data:
The safety and/or performance information that is generated from
the u of a device. Clinical data are sourced from:
— clinical investigation(s) of the device concerned; or
— clinical investigation(s) or other studies reported in the
scientific literature, of a similar device for which equivalence
to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical
experience of either the device in question or a similar device
for which equivalence to the device in question can be
demonstrated.
Clinical Evaluation:
The asssment and analysis of clinical data pertaining to a medical
device to verify the clinical safety and performance of the device
when ud as intended by the manufacturer.
Clinical Evidence:apoint
The clinical data and the clinical evaluation report pertaining to a
medical device.
Clinical Investigation:
Any systematic investigation or study in or on one or more human
subjects, undertaken to asss the safety and/or performance of a
medical device.
Clinical Investigation Plan:
Document that states the rationale, objectives, design and propod
analysis, methodology, monitoring, conduct and record-keeping of
the clinical investigation.
Clinical Performance:
The ability of a medical device to achieve its intended purpo as
claimed by the manufacturer.
Clinical Safety:
The abnce of unacceptable clinical risks, when using the device
according to the manufacturer’s Instructions for U.
