What if I'm not ready for EU MDR on May 26, 2021?
RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.
The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:
No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done correctly
No, you should not start calling your medical device software not a medical device to avoid compliance
No, you should not ignore your non-medical accessory software that's part of your system when implementing the MDR. The notified bodies are not letting this pass.
No, you should not start with a weak PMS plan to enable hitting the target date with an intention to revise before your next surveillance audit.
The above strategies can put your company's CE marking and reputation with the notified body in serious jeopardy. However, there are effective strategies for staying on the market as long as possible while also remaining compliant. Please join our former notified body leaders and regulatory subject matter experts for an informative discussion and bring your questions and ideas!
Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
Felicia Hosey, RAC - Senior Principal Specialist
Brian Hockett - Principal Engineer
Bring your questions and join the discussion!