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MEDDEV 2.1-2 : REV 2 1994

Current
Current

The latest, up-to-date edition.

FIELD OF APPLICATION OF DIRECTIVE 'ACTIVE IMPLANTABLE MEDICAL DEVICES' (90/385/EEC)
Available format(s)

Hardcopy

Language(s)

English

Published date

04-26-1994

I. FIELD OF APPLICATION - DEFINITIONS
II. CLASSIFICATION OF MEDICAL DEVICES
    COVERED BY DIRECTIVE 93/42/EEC
III. CONFORMITY ASSESSMENT PROCEDURES
IV. CUSTOM MADE DEVICES
V. DEVICES INTENDED FOR CLINICAL INVESTIGATIONS
VI. MEDICAL DEVICE VIGILANCE
VII. USE OF LANGUAGES
VIII. TRANSITIONAL PERIOD

Includes the placing on the market and putting into service of 'active implantable medical devices'.

DevelopmentNote
Available for free download. (01/2017)
DocumentType
Miscellaneous Product
Pages
5
PublisherName
European Union
Status
Current

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

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