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  DIRECTIVE 93/42/EEC

concerning
medical devices
14th June 1993
(Medical Devices Directive, MDD)

Contents

Introduction Considerings
Article 1 Definitions, scope
Article 2 Placing on the market and putting into service
Article 3 Essential requirements
Article 4 Free movement, devices intended for special purposes
Article 5 Reference to standards
Article 6 Committee on Standards and Technical Regulations
Article 7 Committee on Medical Devices
Article 8 Safeguard clause
Article 9 Classification
Article 10 Information on incidents occuring following placing of devices on the market
Article 11 Conformity assessment procedures
Article 12 Particular procedure for systems and procedure packs
Article 13 Decisions with regard to classification, derogation clause
Article 14 Registration of persons responsible for placing devices on the market
Article 15 Clinical investigation
Article 16 Notified bodies
Article 17 CE marking
Article 18 Wrongly affixed CE marking
Article 19 Decision in respect of refusal or restriction
Article 20 Confidentiality
Article 21 Repeal and amendment of Directives
Article 22 Implementation, transitional provisions
Article 23 concerns


Annexes of the Medical Devices Directive

Annex I ESSENTIAL REQUIREMENTS
Annex II EC DECLARATION OF CONFORMITY (Full quality assurance system)
Annex III EC TYPE-EXAMINATION
Annex IV EC VERIFICATION
Annex V EC DECLARATION OF CONFORMITY (Production quality assurance)
Annex VI EC DECLARATION OF CONFORMITY (Product quality assurance)
Annex VII EC DECLARATION OF CONFORMITY
Annex VIII STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
Annex IX CLASSIFICATION CRITERIA
Annex X CLINICAL EVALUATION
Annex XI CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
Annex XII CE MARKING OF CONFORMITY

EUROPE MED DEV NET

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