Quantification of clinical benefits/ claims and demonstration of sufficient clinical evidence is one of the most critical elements to achieving MDR certification, and it extends beyond your CER to risk management, PMS, PMCF, and labeling. ECLEVAR will help you to collect the clinical data and integrate that into the CER, PMS and risk management.
Get support from ECLEVAR to solve your non-conformity
Principal clinical project manager, Germany
Clinical Evaluation Report Expertise :
More than 14 years of medical writing expertise at Namsa. Since 2012, authored and co-authored more than 130 clinical evaluation reports (CERs) for all class medical devices (class I, IIa/IIb and III) according to the MEDDEV 2.7.1 Rev. 3 (2009) and MEDDEV 2.7/1 Rev. 4 (2016), MDD, EU Medical Device Regulation (MDR) 2017/745 and In-Vitro Medical Device Regulation (IVDR) 2017/746.
The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.
In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.
Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.
Clinical evaluation report (CER) is a document that describes the device under evaluation, the clinical claims, and the State of the Art of the device group. The documents summarize the clinical data that prove the clinical efficacy and safety of the device under evaluation. The CER use scientifically and systematic sound methods for the assessment and analysis of clinical data to verify the benefice and risk of the medical device when used as intended by the manufacturer.
A non-quantified or defined clinical claims and clinical benefits.
Sometimes, the route of equivalence is misused.
Principal medical writers at ECLEVAR are more than 5 years’ experience to 14 years of experience in medical writing.
ECLEVAR MEDTECH has medical surgeons in the board who works half time in the hospital and part time at ECLEVAR to support in defining the key words, the alternative therapeutics and review the state of the Art.
Yes, recent CERs have received positive feedback from notified body for MDR recertification.