The fact sheet states that transparency is a key objective of the MDR aiming at providing a large access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. 

The transparency requirements can be divided into two 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.

Most of the requirements on Transparency and public access to information are linked to the new version of EUDAMED, which is planned to become fully functional by May 2022. The public access to the information registered in the different modules of EUDAMED will be extensive.

The European Commission announced in their “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” that the EUDAMED actor registration module, to obtain the Single Registration Numbers (SRN), is planned for Q4 2020, while the device and certificates modules are planned for Q2 2021. A guidance on administrative and technical solutions in the absence of EUDAMED and a position paper on the use of the actor registration module in Member States should be endorsed by Q3 2020.

What does this mean to you?

This fact sheet will allow you to gain an understanding of what information will become publicly available and will help you prepare accordingly.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us

 

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