Eudamed Accessibility for Non-European Authorities
EMERGO SUMMARY OF KEY POINTS:
- Some information in Eudamed will be publicly accessible.
- Typically, non-European authorities only have access to publicly available Eudamed data.
- The MDR and IVDR keep the option open for non-European countries to exchange data with Eudamed and have access to data that is not publicly accessible, based on reciprocity.
- The European Commission has indicated IMDRF members of the NCAR system will be the first to get extended access.
- Eudamed could be a new world standard in data exchange regarding device safety.
The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry.
Public versus regulatory accessibility to Eudamed
The European Database for Medical Devices (Eudamed) under the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) will be partially accessible to the public. “The public” means in this context anybody with access to the Internet, anywhere the world.
Publicly accessible information mainly concerns devices, economic operators (manufacturers, authorized representatives, importers, sponsors), Notified Bodies, certificates and field safety notices. Other information, like most of the communication between Competent Authorities and economic operators, will only be accessible to a limited group of users. These economic operators will of course have access to their own data. They will not have access to the limited accessible data of other economic operators, unless they are somehow granted access by the owner of that data.
This is for example the case for non-European manufacturers that use an Authorized Representative and an importer for placing their devices on the market. It speaks for itself that non-European manufacturers have the same access rights to their own data as their European colleagues.
For Competent Authorities, this is different. Article 33.5 of the MDR grants access to all data in Eudamed for the Authorities of Member States of the EU/EEA. And, access to Eudamed for the UK will be part of the Brexit negotiations. Outside of these countries, no other regulators will have the same level of access as the Member States, but of course they have the same access as the general public. All this implies that information about incidents and trend reporting will not be available for non-European regulators.
Realization of MDR Article 92.4?
However, Article 92.4 of the MDR states that the European Commission can grant Eudamed access to authorities in other countries for data that is not available to the public. A European Commission official has confirmed to Emergo that this option is now openly under consideration, so it is likely this article will not remain an empty legal option.
Article 92.4 also points out that such access can only be granted on the basis of reciprocity. Considering the most critical non-public data for authorities, it is likely data exchange on this level will be about incidents and field safety corrective actions. Combining data from multiple markets may result in faster identification of a potential risk.
NCAR members may get earlier Eudamed access
The European Commission has indicated that the first countries allowed access to Eudamed will likely be those that already take part in the National Competent Authority Report (NCAR) exchange program of the International Medical Device Regulators Forum (IMDRF). Data exchange using Eudamed will be an extension to the NCAR system. As most of the IMDRF members and associated countries are involved in implementing a UDI system, Emergo expects the UDI databases for medical devices will eventually have a high degree of compatibility with Eudamed.
Eudamed constitutes a highly ambitious project, with many challenges and very short timelines. But, if working well, it has the potential of becoming a world standard in medical devices safety information exchange. The first version may not be perfect. Therefore it is important that all parties currently involved now remain engaged in developing future versions of Eudamed.
Related European medical device regulatory resources:
- European medical device and IVD market regulatory strategy report
- European medical device vigilance and incident reporting consulting
- Whitepaper: European MDR transition timelines and strategies
- Webinar: Europe’s MDR 2017/745