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MEDDEV 2.4-1 : REV 9 : 2010

Current

Current

The latest, up-to-date edition.

CLASSIFICATION OF MEDICAL DEVICES

Available format(s)

Hardcopy

Language(s)

English

Published date

01-06-2010

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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