Preparing your CER for MDR blog

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 for 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 now.

The Clinical Evaluation Report (CER) is required under the regulations. Past practice of basing the device safety and performance on competitive or comparative devices with written justification for no post-market clinical follow-up may no longer satisfy the requirements. However, if you take the time during the transition period to gather clinical evidence on these devices, you will be prepared to meet these requirements.

This webinar will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but R&Q experts will be able to help you navigate the process.

Access the on-demand webinar

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!