Do you need a clinical evaluation to achieve CE approval, or to determine the safety and performance of your medical device?
The clinical evaluation is a document that evaluates whether your device is at least as safe and effective as equivalent devices already on the European market.
By means of literature and/or own clinical data our clinical evaluations can help you to
- achieve CE approval
- identify equivalent devices
- demonstrate safety and performance
- determine the objectives of your upcoming clinical investigation
CERES can support you in performing, writing, and maintaining your clinical evaluation. According to MEDDEV 2.7/1 rev. 4, MDCG 2020-5 and MDCG 2020-6 we perform systematic searches for relevant clinical studies, literature and registries that included equivalent devices. Then, we review and analyse the available clinical data.
Whether you can achieve CE approval for your medical device using solely a literature-based clinical evaluation, or already available clinical data are sufficient, or a clinical trial is required strongly depends on your device, and already available data confirming safety and performance.
After achieving CE approval, the manufacturer is responsible for keeping clinical data for the device up-to-date. Post-Market Clinical Follow-up (PMCF) studies are helpful for market surveillance. Also Post-Market studies potentially increase your market presence and innovation potential.