EU
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
EU
The article highlights the key points related to the regulatory framework for reporting requirements in the context of certain studies medical devices are subject to.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
