Aug 12, 2020

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

Key device-related data available through Eudamed

Major information targeted for public accessibility within Eudamed includes:

  • Registration details of manufacturers, Authorized Representatives and importers
  • Registration of devices as well as Unique Device Identification (UDI) database elements listed in part B of Annex VI of the MDR
  • Certificate of conformity registration details
  • List of Notified Bodies designated under the MDR, along with their identification numbers, conformity assessment activities and lists of their subsidiaries
  • Expert panel scientific opinions, as well as written justifications for instances where Notified Bodies have not followed pertinent expert panel opinions
  • Reports and summaries of clinical investigations
  • Safety and clinical performance report summaries for implantable and Class III devices
  • Manufacturer incident reports and field safety notices
  • Market surveillance activity result summaries from European Union Member States

Data available to the public outside Eudamed

Beyond the Eudamed database, European regulators plan to disseminate other device-related information to the public using other channels. These include:

  • Competent Authority measures to place single-use, reprocessed devices on EU markets
  • Fee levels and types set by EU Member States for funding efforts carried out by Competent Authorities
  • Member State-level measures overseeing assessment, designation and notification of Notified Bodies
  • List of standard fees levied by Notified Bodies
  • Member State report summaries on monitoring of Notified Bodies
  • Annual reports on peer review activities of entities overseeing Notified Bodies
  • Pertinent declarations of interest of top-level management of Notified Bodies
  • Pertinent declarations of interest of Medical Device Coordinating Group (MDCG) members, sub-group members and expert panel advisors
  • Advice provided by expert panels
  • Name and affiliate information of each MDCG member

European Commissioners may expand the scope of information to be made publicly available in the future.

“Transparency in the context of the MDR can be considered as a step by step process that may include other areas in the future,” states the factsheet.

Related European MDR and Eudamed information for medical device and IVD manufacturers:

Author

  • Stewart Eisenhart

Related