Medical Device Clinical Evaluation Report

A Clinical Evaluation Report (CER) for medical device consists of documents collected either from clinical trials , or from similar or equivalent data search online. The Clinical Evaluation Report conclusion demonstrates your device achieves its intended purpose without posing any risk to patients.

Clinical Evaluation Reports are part of the Technical File submitted to Notified Body.  We support Clinical Evaluation documentation as per Article 61 of New MDR and Meddev 2.7/1 Revision 4.

 

Contact us for guidance