Note: R&Q's first Intelligence Series webinar of 2018 will be held on January 23rd – QMS for EU MDR: Does your quality system meet the additional requirements? Sign up here!
Back in November and as part of the R&Q Intelligence Series, we held the webinar, Preparing your CER for MDR: Gathering Clinical Evidence.
The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is most certainly now.
At the conclusion of the November webinar we answered many questions (the most of any webinar - so thank you!), and some of those questions and answers are below. To read more about the webinar, read all questions and answers, and gain access to the slides and recording, check out the on-demand webinar.