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This directive applies to products according to Article 2.C AIMDD, which are
defined as: 'active implantable medical device' means any active medical device
which is intended to be totally or partially introduced, surgically or
medically, into the human body or by medical intervention into a natural
orifice, and which is intended to remain after the procedure... Demonstrating
compliance with the Medical Directives in order to affix the CE Marking may
require the services of a Notified Body for part or all of the following
operations:
- Type testing
- Examination of the design
- Assessment of the manufacturer's Quality Management System (compliance with
EN 46000 standards)
- Evaluation of the clinical data
Products must meet the essential
requirements of the directives, which include product safety, EMC,
biocompatibility and others, as well as effectiveness and functionality.
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