The article highlights the key points related to the regulatory requirements for performance studies involving in vitro diagnostic medical devices. Table of Contents Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to...
The new article highlights the aspects related to post market activities intended to ensure continuous safety and proper performance of medical devices allowed to be marketed and used in the country. Table of Contents The Medicines and Healthcare Products Regulatory...
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...
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
The new article describes in detail the aspects related to the existing premarket requirements and the improvement they require. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare...
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...