Medical Devices Consulting

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