The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

The Medical Device Amendments of 1976 were supposed to be written up and put into law in the early 1960s. But, as Peter Barton Hutt told MD+DI in a 1996 interview about the development of the Medical ...

Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of ...

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, ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...

On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...

Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...

Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure ...

LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...