MEDDEV 2.1-2 : REV 2 1994
Current
The latest, up-to-date edition.
FIELD OF APPLICATION OF DIRECTIVE 'ACTIVE IMPLANTABLE MEDICAL DEVICES' (90/385/EEC)
Hardcopy
English
26-04-1994
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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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