Di Renzo Regulatory Affairs
Pills
Medical Devices

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.

 

In this sector we provide the following services:  

    • Provide clients with information on current Italian and European laws
    • Consultancy on obtaining the CE mark through Notified Bodies
    • Notification of the devices, upon proxy of the manufacturer, in the National Register and Index according to the modalities provided by the Decree of the Ministry of Health of the 20th of February 2007 and following updates
    • Organise applications for Free Sale Certificates and other documentation
    • Organise applications for medical device promotional materials

    www.medicadevice.info