Clinical Evaluation Report (CER)
The evidence in terms of clinical performance, benefit and safety is to be documented in the CER. Thus, the CER is the central clinical document for regulatory approval of your device and is-especially since entry into force of the MDR-strictly reviewed by your Notified Body. The CER discloses the benefit-risk ratio of your device and defines measures to keep this ratio positive and acceptable.
- LITERO offers the compilation of the Clinical Evaluation Plan (CEP) and CER according to MDR Article 61 and Annex XIV Part A, as well to MEDDEV 2.7/1 and MDCG guidelines. In addition, we compile the Literature Search Report for you as an integral part of the CER.
- Is the clinical evidence of your device based on clinical data related to an equivalent device? In that case we support you by a demonstration of equivalence according to the MDR requirements.
- Are the conclusions of the CER regarding performance, benefits and (residual) risks adequately reflected in related documents such as Risk Management, Periodic Safety Update Report (PSUR) and/or Instructions for Use? We check your documentation and support you in your process development.