EU MDR/IVDR On May 5th, 2017 the European Union Medical Device Regulation (EU MDR) was officially published and was entered into force on May 26th, 2017. The new regulation, which is binding in its entirety, will have a direct effect on the medical manufacturing industry as...
North America As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
Europe The Ministry of Health of the Russian Federation is the country’s regulatory body for healthcare concerns. They recently released a change in regulation for medical devices. All Medical Device Registration Licenses issued from 1 January 2007 to 31 December 2012...
Asia The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of medical device clinical trials and devices that may be...
North America The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
