The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in May 2017 has new, stricter criteria for CER (Clinical Evaluation) reports, such as the basis of establishing an equivalence with another device and the quality of data considered in your clinical evaluation.
We consider the 5 issues that you should consider when creating a Clinical Evaluation Report.