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MEDDEV 2.7-1 : REV 4 2016

Current
Current

The latest, up-to-date edition.

CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC
Available format(s)

Hardcopy

Language(s)

English

Published date

01-06-2016

1. Introduction
2. Scope
3. References
4. Definitions
5. Abbreviations
6. General principles of clinical evaluation
7. Definition of the scope of the clinical
    evaluation (Stage 0)
8. Identification of pertinent data (Stage 1)
9. Appraisal of pertinent data (Stage 2)
10. Analysis of the clinical data (Stage 3)
11. The clinical evaluation report (CER, Stage 4)
12. The role of the notified body in the assessment
    of clinical evaluation reports
Appendices
A1. Demonstration of equivalence
A2. When should additional clinical investigations
     be carried out?
A3. Device description - typical contents
A4. Sources of literature
A5. Literature search and literature review protocol,
     key elements
A6. Appraisal of clinical data - examples of studies
     that lack scientific validity for demonstration of
     adequate clinical performance and/or clinical
     safety
A7. Analysis of the clinical data - compliance to
     specific Essential Requirements
A8. Devices for unmet medical needs - aspects to
     consider
A9. Clinical evaluation report - proposed table of
     contents, examples of contents
A10. Proposed checklist for the release of the
     clinical evaluation report
A11. Information on declarations of interests
A12. Activities of notified bodies

Supports a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC.

DevelopmentNote
Available for free download. (01/2017)
DocumentType
Miscellaneous Product
Pages
65
ProductNote
This standard also refers 722/2012, NBOG BPG 2006-1, NBOG BPG 2009-1, NBOG BPG 2009-4, NBOG BPG 2010-2, NBOG BPG 2014-1, NBOG BPG 2014-2, NBOG BPG 2014-3, GHTF SG5 N1R7:2007, GHTF SG5 N2R8:2007, GHTF SG5 N41R9:2005
PublisherName
European Union
Status
Current

AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
MEDDEV 2.7-4:2010 GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
MEDDEV 2.7-2 : REV 2 GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
MEDDEV 2.4-1 : REV 9 : 2010 CLASSIFICATION OF MEDICAL DEVICES
MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
MEDDEV 2.7-2 : REV 2 GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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