European Commissioners have issued a new factsheet detailing types of information related to medical devices and IVD products to be accessible to the public via the Eudamed database.
According to the factsheet, the information to be made available to the public via Eudamed is required to meet transparency obligations under the forthcoming European Medical Devices Regulation (MDR). European regulators anticipate Eudamed to become fully operational by May 2022, roughly one year following the MDR’s date of application.
The EC factsheet explains that two key categories of information will be accessible to the European public in order to meet MDR obligations:
- Medical device and IVD data available through the Eudamed database
- Data made available via means other than Eudamed by the EC, Competent Authorities, Notified Bodies or other stakeholders…