While MedTech development has always been complex, the implementation of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have brought about increased scrutiny of technical documentation. Now, regulators review complete data stories during submission approval, necessitating a more robust process for continuous collection and analysis of clinical and performance data. If you want to obtain a CE certification, you need to document this data in a Clinical Evaluation Report (CER) and update it every year or every 2-5 years depending on post-market information and your desired risk level. But CERs are complex, often demanding more time and resources than you can spare — especially if you have a moderate or large portfolio of medical devices.
Avania’s CER framework takes the complexity and stress out of IVDR medical writing, allowing for efficient updates to your evaluation reports as well as cost and time savings. Our proven CER solutions have resulted in:
- Close to 20 successful evaluation report submissions every year with each framework containing up to 30 individual reports
- Execution of new workflows and CER and PMCF plan delivery within 6 weeks
- Significant reduction in 80% time and 70% costs to do the periodic CER updates
Download our case study on our CER services to explore how Avania achieves these results and what we can do for your MDR and IVDR medical writing.