Clinical Evaluation Reports – EU MDR

Get CER support from a team that knows the requirements, inside and out.

Producing clinical evaluation reports (CERs) for medical devices can be a complex and challenging process, involving these major hurdles:

  • Determining the right amount and quality of clinical data considering regulatory ambiguity, data availability and data integration.
  • Meeting evolving regulatory expectations with continuous updates and differing interpretations by notified bodies.
  • Balancing cost and efficiency given resource limitations and opportunities to use technology such as AI to streamline the process.

AlvaMed has experience with CERs, particularly with respect to EU MDR compliance. We know what notified bodies are expecting, and we will prepare your team and documentation accordingly.

Determine device classification per EU MDR requirements.

Thorough review of the data on your product, from internal pre- and/or post-market clinical studies and those conducted outside of your organization.

Creation of an MDR-compliant Clinical Evaluation Plan, which will guide the completion of the process.

Plan, execute and report on relevant peer-reviewed literature on subject matter.

Execute an MDR-compliant CER derived from the Clinical Evaluation Plan.

Create or update PMCF Plan based on perceived areas of needs based on the findings of the Clinical Evaluation.

AlvaMed is uniquely positioned to help you create a strategy for presenting comprehensive clinical evidence and analysis.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

Clinical Evaluation Reports – EU MDR FAQ's

The length of the project is dependent on multiple areas, including Device Classification; New/Legacy Approval; Amount of Clinical Study Data; Number of Peer-reviewed literature articles to review and number of safety incidents. Reach out to us directly, to have a conversation about your specific product needs.

Certain products will require a level of clinical study evidence, such as Class III and implantable devices.

Robust safety and performance data from high-quality clinical studies, covering each device indication, is the benchmark.

Kerry Beckett

Clinical and Regulatory Affairs Manager

Kerry has assembled CERs across a wide spectrum of medical device indications, for small one product clients up to large multi-national clients with an array of clinical products. A thorough researcher, she is able to understand the intricacies of your products clinical background, in order to assemble the most complete documentation of its’ clinical results. She then uses her extensive experience in successfully distilling this information into the CER to support the interactions with your notified body to bring you into compliance with current MDR standards.