In the European Union the marketing of medical devices is regulated by European standards. A medical device, once it has obtained the CE mark in a European country, can move freely in other European countries.
The activities that this unit is able to perform relate to the following items:
- Advice on current legislation in Italy, Europe and in certain non-European countries in relation to medical devices.
- Registration of medical devices and in vitro diagnostic devices in the European Member States (Italy, France, Spain, Portugal and so on)
- Selection of the appropriate GMDN code required for the registrations. Di Renzo is a registered member of the GMDN Agency and have access to the GMDN database.
- Preparation of technical dossiers in order to obtain the CE mark
- Contacts with Notified Bodies and consultancy for obtaining CE marking
- Gap analysis on the documentation available from companies for marketing authorizations for devices in non-European countries
- Device-vigilance in Italy and Europe
- Assuming the role of QA / RA as defined by the forthcoming European Regulation on medical devices.
- Assuming the role of Authorized representative (direct contacts with the competent authorities of the EU and management of post-marketing surveillance)
- Preparation of documents required for Class I devices and technical declarations of compliance issued by Di Renzo Regulatory Affairs