(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DIRECTIVE 93/42/EEC
of 14 June 1993
concerning medical devices

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