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Compliance with the AIMDD-90-385-EEC
Demonstrating compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following:
- Essential Requirements
- General requirements (” The devices must be designed and manufactured in such a way, that their use does not compromise the clinical condition or the safety of patients.”)
- Requirements regarding design and construction
EC Declaration of Conformity (Complete quality assurance system)
- Quality system
- Examination of the design of the product
- Surveillance
- Administrative provisions(the declaration of conformity)
EC Type- Examination
- Make an application for evaluation of quality system to a notified body (Annex III, section 3)
- EC verification
EC Declaration of Conformity to Type
- Quality system
- Surveillance
- Statement concerning devices intended for special purposes
Clinical evaluation
- Clinical investigation (purpose, ethical consideration, methods)
- Minimum criteria to be met when designating inspection bodies to be notified
- CE conformity marking
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