EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
Europe
HDR UK will release seven new health data hubs, providing over 100 doctors, scientists, and researchers with the medical histories of millions of NHS patients. They aim to aid research for new medicines, treatments, and technologies across the country, HDR’s...
EU MDR/IVDR
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25...
Europe
Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both manufacturers and regulatory authorities. The European...
Asia
Learn about what Global Medical Device Regulations regulatory stands for: If you are strong exporter of medical devices, you should know about global medical device regulations. Canada The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the...
