On 25 February 2020, the World Trade Organisation (WTO) held a Thematic Session on Good Regulatory Practice in Geneva with two panels, one on Medical Devices and another on New Vehicle Technologies. The Medical Devices panel focused on encouraging regulatory compatibility and cooperation, and included presentations from representatives of agencies from the United States, Canada, the EU, and Japan. The various presenters introduced the current Medical Device context of their regions, and collectively discussed some challenges for auditing medical devices, as well potential solutions, and the role of the WTO.
The Thematic Session provided global context of the regulatory medical device landscape, including common international frameworks. There appears to be a general global regulatory burden surrounding medical devices and many concerns were raised regarding the EU’s new MDR and In-Vitro Device Regulation (IVDR). For instance, several non-EU countries voiced concerns over the pace of its implementation, claiming it may lead to harming patient access to medical technologies.
You can find more details about this Thematic Session here.
MDR: Global perspectives
