MedNet as your Authorized Representative for medical devices acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Medical Device Directive MDD 93/42/EEC as well as additional services regarding the marketing of your medical devices within the European Community.
What is a Medical Device?
According to the Medical Device Directive MDD 93/42/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.
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 technical file including 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
- Medical Device Directive (93/42/EEC)