Non-European Authority access to Eudamed

Eudamed functional specifications are expected to be released in May 2018, with Eudamed predicted to go live in March 2020. To increase the sharing of device safety information, the European Commission is considering extending access to the Eudamed medical device database to non-European regulators. Typically non-European authorities only have access to publicly available Eudamed data, however Eudamed could become a new world standard in data exchange regarding medical device safety.  

The public will have partial access to the European Database for Medical Devices (Eudamed) under the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR). Information that will be available to the public concerns devices, economic operators (manufacturers, importers, sponsors and authorised representatives), Notified Bodies and field safety notices. It is proposed that information regarding the communication between Competent Authorities and economic operators will only be accessible to a limited group of users.

Economic operators will not have access to the limited accessible data of other economic operators, unless they are granted access by the owner of that data. For example, this is the case for non-European manufacturers that use an Authorised Representative and an importer for placing their devices on the market; non-European manufacturers have the same access rights to their own data as their European counterparts.

However this is different for Competent Authorities as Article 33.5 of the MDR grants access to all data in Eudamed for the Authorities of Member States of the European Union (EU)/European Economic Area (EEA). Whether the United Kingdom (UK) will have access to Eudamed will be discussed as part of the Brexit negotiations. It currently looks like incident and trend reporting will not be available for non-European regulators.

According to Article 92.4 of the MDR, the European Commission can grant Eudamed access to authorities in other countries for data that is not available to the public, therefore this option is under consideration. Although access such as this may only be granted on the basis of reciprocity. The exchange of data on this level is likely to be regarding incidents and field safety corrective actions.

It is thought that International Medical Device Regulators Forum (IMDRF) members of the National Competent Authority Report (NCAR) system will be among the first to have access to Eudamed. The majority of the IMDRF members and associated countries are involved in implementing a Unique Device Identification (UDI) system, thus it could be expected that the UDI databases for medical devices may be compatible with Eudamed.