The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...

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.

Many medical devices need to be sterile to be used safely. But sterilizing a pacemaker, catheter, or other device with steam or heat could damage its structural integrity. So medical device ...

On 16 December 2025, the European Commission put forward a proposal for a regulation to simplify the rules governing medical devices in the EU.

Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change ...

The designation follows an extensive assessment using the WHO Global Benchmarking Tool Plus for Medical Devices (GBT+MD).

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 ...