The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulatory authorities worldwide that work together to promote international harmonisation and alignment of medical device regulations.
International harmonisation provides an important basis for reducing the regulatory workload for both authorities and companies and for exploiting synergies through cooperation.
Swissmedic has been actively involved in international harmonisation work for many years. Since 2021, Swissmedic experts have been engaged in various working groups that are seeking to further optimise the international regulation of medical devices.
In March 2023, Swissmedic (the Swiss agency for therapeutic products) was – at its own request – granted the status of Official Observer in the IMDRF's Management Committee. This has allowed it to become more closely involved in strategic discussions and has laid the foundations for further integration.
In March 2025, also at Swissmedic's request, it was accepted as a member of the Management Committee (MC). Acceptance to the Committee underlines the many years of constructive cooperation and testifies to the trust that the international partners have in Swissmedic's regulatory expertise.
Swissmedic will continue to actively contribute to the work of the IMDRF in order to further strengthen and promote international regulation of medical devices.
Public consultation:
Stakeholders from Switzerland also have the opportunity to provide feedback on the IMDRF documents. The open consultation process can be accessed at the following link: IMDRF consultations. Comments (in English) can be sent directly to the addressees specified by IMDRF using the appropriate feedback form that it has provided. Please copy imdrf@swissmedic.ch into your mails. You will receive a confirmation of receipt of your comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible IMDRF working groups and taken into account where appropriate.