MEDDEV 2.4-1 : REV 9 : 2010
Current
The latest, up-to-date edition.
CLASSIFICATION OF MEDICAL DEVICES
Hardcopy
English
01-06-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
1. PURPOSE AND PHILOSOPHY OF MEDICAL
DEVICE CLASSIFICATION
2. PRACTICAL RELEVANCE OF CLASSIFICATION
3. HOW TO CARRY OUT CLASSIFICATION
4. EXPLANATIONS OF INDIVIDUAL RULES
Covers guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC, as amended. Pertains to the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Miscellaneous Product
|
| Pages |
51
|
| 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 2.7-2 : 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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