Active Implantable Medical Devices
MedNet as your Authorized Representative for active implantables acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Active Implantable Medical Devices Directive as well as additional services regarding the marketing of your active implantables within the European Community.
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;
For MedNet to act as your European Authorized Representative, the manufacturer must complete the following steps:
- The product compliance must be ensured
- The product must be classified
- A Notified Body must be involved (for products other than class I) and the Declaration of Conformity must be prepared
- The CE mark must be affixed and labeling has been completed
- The Authorized Representative must be included in the manufacturer’s product liability insurance
- An agreement between manufacturer and MedNet has to be signed
- Active Implantable Medical Devices Directive (90/385/EEC)