July 2020: Medical Device Regulation (MDR) Update

As per the State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR, the priority action for transparency was to issue a fact sheet on information to become publicly accessible.

This Factsheet on MDR requirements for Transparency and Public Information has been published on July 15, 2020. Most of the requirements on Transparency and public access to information are linked to the Eudamed, which is planned to become fully functional by May 2022.

The transparency requirements under the MDR can be divided into different categories:

  • Information on medical devices made accessible to the public in Eudamed
  • Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies

Thus, the fact sheet has presented the MDR transparency requirements separately depending on whether they will be available in or outside the Eudamed database.

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