MEDDEV 2.7-2 : REV 2
Current
The latest, up-to-date edition.
GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
Hardcopy
English
01-09-2015
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0. PREFACE
1. INTRODUCTION
2. SCOPE
3. References
4. DEFINITIONS
5. ETHICAL CONSIDERATIONS
6. VALIDATION
7. ASSESSMENT
8. DECISION ON APPROVAL/AUTHORIZATION
9. INFORMATION TO BE EVALUATED DURING
THE CONDUCT OF A CLINICAL INVESTIGATION
AND AT THE END
APPENDICES
1a: List of the standards applied in full or in part
1b: Matrix of Essential Requirements applicable to IMD
2: Guidance notes on medical devices incorporating a
medicinal substance having ancillary action
3: Guidance on medical devices which require sterilization
4: Guidance on clinical investigations of active devices
5: Guidance on clinical investigations of software
6: Guidance on medical devices incorporating tissues
of animal origin
7: Clinical investigation application form
8: Clinical investigation validation checklist
9: Clinical investigation assessment checklist
Gives guidance to Competent Authorities when validating/assessing a clinical investigation application according to Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC provided by manufacturers/sponsors from the initial application up to the end of the investigation.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Miscellaneous Product
|
| Pages |
68
|
| PublisherName |
European Union
|
| Status |
Current
|
| MEDDEV 2.7-1 : REV 4 2016 | CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC |
| MEDDEV 2.7-4:2010 | GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
| MEDDEV 2.7-1 : REV 4 2016 | CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC |
| MEDDEV 2.1-2 : REV 2 1994 | FIELD OF APPLICATION OF DIRECTIVE 'ACTIVE IMPLANTABLE MEDICAL DEVICES' (90/385/EEC) |
| MEDDEV 2.1-3 : REV 3 : 2015 | BORDERLINE PRODUCTS, DRUG-DELIVERY PRODUCTS AND MEDICAL DEVICES INCORPORATING, AS INTEGRAL PART, AN ANCILLARY MEDICINAL SUBSTANCE OR AN ANCILLARY HUMAN BLOOD DERIVATIVE |
| MEDDEV 2.4-1 : REV 9 : 2010 | CLASSIFICATION OF MEDICAL DEVICES |
| MEDDEV 2.1/6 : REV 1 : 2016 | QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE |
| MEDDEV 2.12-2 : REV 2012 | POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| MEDDEV 2.7-3 : REV 3 : 2015 | CLINICAL INVESTIGATIONS: SERIOUS ADVERSE REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
| MEDDEV 2.1-2.1 : REV 1 1998 | TREATMENT OF COMPUTERS USED TO PROGRAM IMPLANTABLE PULSE GENERATORS |
| MEDDEV 2.7-4:2010 | GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
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