A Few New Challenges with EU MDR
The upcoming EU Medical Device Regulation (MDR) was a popular topic at MD&M West, as the industry is working to understand specific requirements as well as any emerging implications. A few specific requirements were examined in the Feb. 11 panel discussion, âStrategies for Implementing the New EU MDR Requirements.â Read on for insights that may surprise you.
Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP)
âWe just became comfortable dealing with post-market surveillance and post-market clinical follow up . . . and now we find ourselves having to understand PSUR and SSCP,â said Jim Talbot, vice president, RA/QA, Zap Surgical, who spoke in the panel discussion. âWhere it gets challenging with PSUR is the requirement for a risk-benefit analysis. Most people struggle with that, and thereâs different approaches you can take.â He added that there is a way to upload PSURs via an e-submission gateway, but he said the template is lacking. âThe content is described, but there is no set template,â he said.
Also, âthe challenge is how you get that information. Most people are familiar with the benefits of their products,â he said. âIt is easy to quantify benefits, but the risks are more difficult to quanti...
Source: MDDI - Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news