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 are legally 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 of interested 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 earlier document 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
Contents Preface (4)
1.0 Introduction (5)
2.0 Scope (6)
3.0 References (7)
4.0 Definitions (7)
5.0 General principles of clinical evaluation (9)documented evidence
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 generated through clinical experience  13
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 Evaluation Report (18)
10  The role of the notified body in the assessment of clinical evaluation data (19)
10.1 Examination of design dossier  20
10.2 Evaluation as part of the quality system procedure 23
10.3 Notified body specific procedure and expertise  24 Appendices (27)
A:    A possible format for the literature search report 28 B:    A possible methodology for documenting the screening and selection of literature        29 within a literature search report
C:  Some examples to assist with the formulation of criteria 30 D:    A possible method of appraisal 32 E:    A possible format for a clinical evaluation report 34 F: Clinical evaluation checklist for Notified Bodies 37
Preface
These guidelines on Clinical Evaluation are part of a set of Medical Device Guidelines that promote a c
ommon 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 charged with safeguarding public health.
They have been carefully drafted through a process of consultation with various interested parties during which comments were taken up in the documents. Therefore, it reflects positions taken in particular by representatives of National Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the MEDICAL DEVICEs sector.
The guidelines are regularly updated accordingly with regulatory developments. The latest version of the guidelines should always be used. This revision of these guidelines has:
•amended the document according to the most recent amendment to the Medical Device Directives (Directive 2007/47/EC) and in the light of experience
•and has carefully considered and transposed into the European context the Global Harmonisation Task Force (GHTF) international regulatory guidance document on clinical evaluation (SG5/N2R8:2007).
These guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.
Nevertheless, due to the participation of the aforementioned interested parties and of experts from National Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, work towards uniform application of relevant EU Directive provisions and common practices within Member States.
However, only the text of the Directives is authentic in law. On certain issues not addressed in the Directives, national legislation may be different from these guidelines.
1. Introduction
What is clinical evaluation?
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
When is clinical evaluation undertaken?
Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use. This information is fed into the ongoing risk analysis and may result in changes to the Instructions for Use.
Why is clinical evaluation important?
When placing a medical device on the market the manufacturer must have demonstrated through the use of appropriate conformity assessment procedures that the device complies with the relevant Essential Requirements covering safety and performance. Generally, from a clinical perspective, it is expected that the manufacturer has demonstrated the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimised and acceptable when weighed against the benefits of the intended performance, and that any claims made about the device’s performance and safety (e.g. product labelling and instructions for use) are supported by suitable evidence.
With regard to post market activities, manufacturers are expected to implement and maintain surveillan
ce programs that routinely monitor the clinical performance and safety of the device as part of their Quality Management System. The scope and nature of such post market surveillance should be appropriate to the device and its intended use. Using data generated from such programs (e.g. safety reports, including adverse event reports; results from published literature, any further clinical investigations and formal post market surveillance studies; etc), a manufacturer should periodically review performance, safety and the benefit-risk assessment for the device through a clinical evaluation, and update the clinical evidence accordingly. This ongoing clinical evaluation process should allow manufacturers to communicate with conformity assessment bodies and Regulatory Authorities in accordance with local reporting requirements, any information that has an important bearing on the benefit-risk assessment of the device or that would indicate a need for labelling changes regarding contraindications, warnings, precautions or instructions for use etc.
What is the process?
To conduct a clinical evaluation, a manufacturer needs to:
•identify the Essential Requirements that require support from relevant clinical data;
•identify available clinical data relevant to the device and its intended use;
•evaluate data in terms of its suitability for establishing the safety and performance of the device;
•generate any clinical data needed to address outstanding issues;
•bring all the clinical data together to reach conclusions about the clinical safety and performance of the device.
The results of this process are documented in a clinical evaluation report. The clinical evaluation report and the clinical data on which it is based serve as the clinical evidence that supports the marketing of the device.
The clinical evidence, along with other design verification and validation documentation, device description, labelling, risk analysis and manufacturing information, is needed to allow a manufacturer to demonstrate conformity with the Essential Requirements and is part of the technical documentation of a medical device.
How detailed should the clinical evaluation be?
A clinical evaluation should be thorough and objective (i.e. it should consider both favourable and unfavourable data), with the intention of demonstrating valid clinical evidence of the safety and perform
ance of the device. However, it is important to recognise that there is considerable diversity in the types and history of technologies used in medical devices and the risks posed by them. Many devices are developed or modified by incremental innovation, so they are not completely novel. Thus, it is often possible to draw on the clinical experience and literature reports of the safety and performance of equivalent devices to establish the clinical evidence, thereby reducing the need for clinical data generated through clinical investigation of the device in question. Similarly, it may be possible to use compliance with recognised standards to satisfy the clinical evidence requirements for devices based on technologies with well established safety and performance characteristics.
The depth and extent of clinical evaluations should be flexible, not unduly burdensome, and appropriate to the nature, classification, intended use, manufacturer’s claims and risks of the device in question. Therefore, this guidance is not intended to impose specific requirements.
2. Scope
The primary purpose of this document is to provide manufacturers and notified bodies with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoin
g marketing. It is also intended to provide guidance to regulators and other stakeholders when assessing clinical evidence provided by manufacturers.
This document provides the following guidance:
•general principles of clinical evaluation;
•how to identify relevant clinical data to be used in a clinical evaluation;
•how to appraise and integrate clinical data into a summary; and
•how to document a clinical evaluation in a clinical evaluation report.
The guidance contained within this document is intended to apply to medical devices generally and the device component of combination products. It is not intended to cover in vitro diagnostics.

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