The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...

Düsseldorf District Court issues preliminary injunction against Beijing Hanbaihan Medical Devices Co., Ltd. regarding ...

Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices ...

Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, ...

DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer ...

The European Commission has published its long-awaited proposal for a regulation amending and simplifying the EU Medical Devices Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices ...

Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) ...