CEF eDelivery webinar for users of European Database on Medical Devices
On 22 May 2019, the CEF eDelivery team co-hosted a webinar with DG GROW for users of the European Database on Medical Devices (EUDAMED).
The CEF eDelivery team introduced the CEF eDelivery building block and provided information on how EUDAMED users can connect to EUDAMED using CEF eDelivery.
Over 290 participants attended this webinar. Additionally, a dedicated hand-on session for a limited group of participants provided guidance on how to send AS4 messages.
EUDAMED is an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission and the Member States’ competent authorities.
The new version of EUDAMED will go live in March 2020. It will be accessible to competent authorities, notified bodies, industry and the public.
This database aims to enhance overall transparency, including better access to information for public and healthcare professionals. In addition, the objective is to avoid multiple reporting requirements, to enhance coordination between the Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and the Member States, and between the Member States among themselves and with the European Commission.
The deployment of CEF eDelivery in EUDAMED is foreseen to have a considerable impact on the market, as this system will allow for the transmission of data from more than 80 000 manufacturers and notified bodies.