Europe – Are You Really Ready For MDR?

Audrey Turley, of Nelson Labs, will speak at Medical Design & Manufacturing Minneapolis about biocompatibility issues related to medical devices including the move to more in vitro testing and the 2020 deadline for the new European Medical Device Regulation.

Audrey Turley doesn’t shy away from speaking about biocompatibility topics related to medical devices. Turley serves as a senior biocompatibility expert for Nelson Labs. The Salt Lake City, UT-based lab serves as an independent consultant that can help navigate these changes for firms.

In a little more than a month, Turley will be speaking at MD&M Minneapolis about Assessing Biocompatibility for Medical Devices. During an interview with MD+DI, she pointed out two main changes in the biocompatibility – the move to the new European Medical Device Regulation (MDR) and the switch from animal to in vitro testing.

“The first is about changes happening in the biocompatibility realm of medical devices and how to address those changes,” Turley told MD+DI. “The second one is about assessing biocompatibility in medical devices in general, where I’m just going to outline the overall approach.”

As it stands now, all medical devices must comply with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD). But by 2020, this will change and new medical device products distributed within Europe must comply with the new European Medical Device Regulation (MDR)…