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EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Consumer Goods
Cosmetics and Medical Devices

MEDDEV. 2.7.1 Rev.3
December 2009

GUIDELINES ON MEDICAL DEVICES

CLINICAL EVALUATION:
A GUIDE FOR MANUFACTURERS AND NOTIFIED
BODIES

The present guidelines are part of a set of guidelines relating to questions of application of EU-Directives
on MEDICAL DEVICEs. They arelegally not binding. The guidelines have been carefully drafted through
a process of intensive consultation of the various interested parties (competent authorities, Commission
services, industries, other interested parties) during which intermediate drafts were circulated and
comments were taken up in the document. Therefore, this document reflects positions taken by
representatives ofinterested parties in the MEDICAL DEVICEs sector.
These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive
90/385/EEC and Council Directive 93/42/EEC and will be applicable as of 21st March 2010. The
transitional period allowing a gradual implementation of the guidelines will therefore end on 20 March
2010.
Note:
This document is a revision of an earlierdocument published in April 2003 as MEDDEV 2.7.1
This document has been drafted on the basis of GHTF Guideline SG5/N2R8:2007 Clinical Evaluation of 29
June 2007 published at www.ghtf.org

page 1 of 46

Contents
Preface............................................................................................................................……4
1.0Introduction...................................................................................................................... 5
2.0 Scope................................................................................................................................ 6
3.0 References........................................................................................................................ 7
4.0Definitions........................................................................................................................7
5.0 General principles of clinical evaluation .........................................................................
6.0 Sources of data/documentation used in a clinical evaluation (Stage 1).......................... 12
6.1 Data generated through literature search
12
6.2 Data generatedthrough clinical experience
6.3 Data from clinical investigations
14
7.0 Appraisal of clinical data (Stage 2)................................................................................. 16
8.0 Analysis of the clinical data (Stage 3) ............................................................................ 17
9.0 The Clinical EvaluationReport....................................................................................... 18
10 The role of the notified body in the assessment of clinical evaluation data…………
10.1 Examination of design dossier
10.2 Evaluation as part of the quality system procedure
10.3 Notified body specific procedure and expertiseAppendices....................................................................................................................…… 27
A:
A possible format for the literature search report
B:
A possible methodology for documenting the screening and selection of literature
within a literature search report
C:
Some examples to assist with the formulation of criteria
D:
A possible method of appraisal
E:
A possible format for a clinical evaluation report
F:
Clinical evaluation checklist for Notified Bodiespage 2 of 46

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Preface
These guidelines on Clinical Evaluation are part of a set of Medical Device Guidelines that
promote a common approach by Manufacturers and Notified Bodies involved in clinical
evaluation procedures according to the relevant annexes of the Medical Devices Directives
and by the National Competent Authorities...