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Structrure of the AIMDD-90-385-eec
The AIMDD 90/385/EEC amended by the 2007/47/EC consists of 17 Articles and 9 Annexes. These Articles define the attributes of a medical device which is characterized according to the directive as well as the harmonized standards that these devices must meet. The Annexes list the general requirements for EC Verification.
Annex1- ESSENTIAL REQUIREMENTS
Annex 2- EC DECLARATION OF CONFORMITY
Annex 3- EC Type-EXAMINATION
Annex 4- EC VERIFICATION
Annex 5- EC DECLARATION OF CONFORMITY TO TYPE
Annex 6- STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
Annex 7- CLINICAL EVALUATION
Annex 8- MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
Annex 9- CE CONFORMITY MARKING
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