MEDDEV 2.7-1 : REV 4 2016
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
Hardcopy
English
01-06-2016
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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 |
| 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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