If a company plans to sell medical devices in Europe, it must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the Medical Device Directive (MDD) or Medical Device Regulation (MDR) 2017/745. Such a CER is compiled by assessing and analysing clinical data regarding a medical device to verify the clinical safety and efficacy of the device.
Prometheus Medical Technologies has a team of expert regulatory professionals together with an extremely large network of clinical experts, through our parent company’s clinical training faculty. Our CER services can provide the following:
- We can collect and examine the required scientific literature applicable to your device
- Compile and write the CER in compliance with EU requirements
- Produce operating procedures to compile CERs
- Complete clinical literature reviews for future updates to your CER
We have the capability to address all the aspects of CER requirements on your behalf. Please email us with your request or query at CER@prometheusdt.com
Prometheus Medical Technologies as a designer, manufacturer and distributor of medical devices for emergency use seeks to achieve excellent product quality, reliability, and patient safety through effective, agile, and compliant processes. We operate under an ISO 13485:2012 Quality Management System which is granted by an external Notified Body (compliance body) when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.