The market is driven by a surge in chronic diseases, increasing adoption of personalized medicine, and rapid technologi ...

The Final Rule was mooted for implementation over a staged transition period, determined by a service’s risk level, by 2028.

In the evolving landscape of medical device regulation ... and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

IVDs are defined in the new EU IVDR legislation as: “Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment ...

Such medical device organisations can be involved ... and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016. He has over 15 years ...

The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals ...

The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: In 2017, new rules were introduced to modernise and update the EU ...