Name: MEDDEV 2.7-2 : REV 2
Brand: EU

GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC

Available format(s)

Hardcopy

Language(s)

English

Published date

01-09-2015

Publisher

European Union

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
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 2.1/6 : 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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MEDDEV 2.7-2 : REV 2

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