AIMD 90/385/EEC

More detailed information

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.