Medtech companies have been working for a couple years to update their approach to biocompatibility testing in preparation for the new ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” which became official last August 2018.
But there may be an even more compelling reason to get up to speed on the new standard—the European Union’s new Medical Device Regulations (MDRs). “We’ve been talking about ISO 10993-1 changes for some time—for medical device manufacturers, this is the central document that defines biocompatibility strategy,” Matthew Jorgensen, PhD, senior E&L expert for Nelson Labs, told MD+DI. “What is special about the landscape today is that the new version of 10993-1 has arrived at the same time as the new European regulations, and the regulations state that companies will have to comply with the latest biocompatibility standards.”
Author: Daphne Allen