the removal of the “sell-off” periods (MDR and IVDR). As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended ...

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.

As journalists, we always hope our words will resonate with readers. But we don't always like the reason why our words strike a chord. This was the experience one of our writers, Heather R. Johnson, ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

Regulations and compliance are generally complex subjects. However, they exist for a clear reason: to ensure that quality and safety standards are met and to reduce potential risks. This is ...

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...