Transcript Webinar on Importance & Requirements of Clinical Evaluation for CER

Importance & Requirements of Clinical Evaluation
for CER
The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more
prescriptive and demanding set of expectations. A sound ongoing procedure to collect,
appraise and analyze clinical data pertaining to a medical device and to evaluate whether
there is sufficient evidence to demonstrate conformity with relevant essential
requirements for performance and safety is very critical. The demonstration of
“equivalence” between subject device and predicate is much stricter now and may lead to
requirement of generating more clinical data with larger patient populations. The
importance of an overall evaluation of the device needs to be emphasized with particular
focus on ensuring that clinical data are evaluated in a systematic and objective way, that
the benefit/risk profile is acceptable and any knowledge gaps are identified and
addressed. Considering the importance & requirement of clinical evaluation for CER
writing and updating, this webinar is planned to focus on the following aspects.

5 stages of Clinical evaluation

New Requirements for justifying Equivalence

PMS & PMCF
Qualifications of the Evaluators

About Our Speaker
Dr C. Lessmann, Ph.D., CER Writer & Expert
Register here: https://www.makrocare.com/webinar-registration-forimportance-requirements-of-clinical-evaluation-for-cer