With the experience and professionalism of the personnel from Di Renzo Regulatory Affairs, we are able to offer the following services for our clients:
- Provide clients with information on current Italian and European laws
- Preliminary examination of company’s project
- 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
- Prepare labels and packaging in the final form for printing
- Translations to and from Italian into the other principal EU languages
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