Active Implantable Medical Devices

MedNet Services for
Active Implantable Medical Devices

• fast product registrations to EU Competent Authorities.
• guidance in the preparation of Declarations of Conformity.
• guidance in the labeling and language requirements in Europe.
• Incident reporting to the competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state.
• notification services for clinical investigations.
• application of Free Sales Certificates / Certificates of Marketability
• provision of Certificates of product registration

What is an Active Implantable Medical Device?

According to the Active Implantable Medical Devices Directive (90/385/EEC) a ‘medical device’ is defined as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• investigation, replacement or modification of the anatomy or of a physiological process
• control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

‘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;