Name: MEDDEV 2.1-2 : REV 2 1994
Brand: EU

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

Available format(s)

Hardcopy

Language(s)

English

Published date

26-04-1994

Publisher

European Union

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