Our experience at the service of new immissions on the market
We carry out preparation and support activities for the registration of medical devices and in vitro diagnostic medical devices at the European Competent Authorities, including the Italian one.
We can process the necessary documentation, carry out requests and effectively manage all the registration stages of your medical devices and IVD.
- Actor registration (EU and non-EU Manufacturers, Authorised Representatives, system/procedure pack Producers and Importers of Medical Devices and In Vitro Diagnostic Medical Devices) in Eudamed database. Thema experts are available to proceed on your behalf or support you in the EUDAMED registration up until the notification to the Ministry of Health of the Member State where the economic operator submitting the application is based. The Ministry will then issue the SRN (Single Registration Number) upon the activation of the authorisation.
- Assessment Gap analysis for notification/registration at the Ministries of Health of the Member States.
- Labelling adjustment (labels, instructions for use).
- Notifications/records of devices in ministerial databases.
- Applications for authorisation advertising.