Several regulatory authorities have provided guidelines for clinical trials (FDA, MHRA, EMA) on how to move to remote monitoring during COVID-19. Even if the MDR is delayed, it is now time to get prepared and plan to hit the ground running with the collection of clinical data.
COVID-19 affects device manufacturers and suppliers significantly. Device manufacturers are likely to see a drop in sales for appliances primarily used in elective and surgical procedures. They are reassessing marketing and revenue forecasts and have to consider how safety measures will impact production lines, as well as any effect on resource allocation and funding of remediation programs for MDR.
Shifting the MDR date of application gives Notified Bodies an opportunity to continue being designated under the new regulation and ready to accept applications from manufacturers. Medical device manufacturers should expect Notified Body availability and reviews to be further delayed by the COVID-19 situation.
The COVID-19 pandemic affects clinical trials, production, and supply chains, as well as Notified Body readiness and other regulatory concerns. However, the lesson is that the medical device industry must still be EU MDR compliant and should not lose its focus. So how will this additional year allow the medical industry to prepare for a completely planned and effective implementation of the MDR? Make sure you join our webinar to find out.
Webinar Registration Is Open Now!
Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR.
Secure Your Place Now!
During this webinar, hosted in conjunction with RAPS, Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR. In addition, you will develop a comprehensive and advanced understanding of potential strategic solutions for MDR compliance, regardless of where you are in the transition process. You will also learn how to take advantage of the extension for both MDD renewal and MDR implementation.
By attending this session, you will gain access to industry and Celegence experts who can answer your questions on the hurdles your organization is facing in MDR certification and recertification under MDD.