Directive 93/42/EEC medical devices

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VER BOLETINES ANTERIORES

DIRECTIVE 93/42/EEC

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

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

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

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