Clinical Evaluation and Clinical Evidence for Medical Devices
What Subject Matter Experts & Manufacturers should know
With the European Medical Device Regulation (EU-MDR) published in 2017, enhanced and new requirements were introduced. Among others, these relate to the systematic collection, evaluation, reporting of clinical data and the continuous demonstration of clinical evidence for safety, performance, and an acceptable benefit /risk ratio of a medical device.
The limitation on equivalent approaches and the expectations on the conduct of clinical investigations and proactive PMCF activities play a crucial role for the demonstration of compliance to relevant General Safety and Performance Requirements (GSPRs). Thus, the EU-MDR increases the expectation on a compliant systematic approach and methods for clinical evaluation throughout the device lifecycle in pre- and post-market phases.
Clinical Evidence is required to specifically demonstrate compliance with at least GSPRs 1 and 8 when drawing-up the Clinical Evaluation Report (CER). The responsibility to provide sufficient clinical evidence lies with the manufacturer.
The training aims at providing a sound understanding of clinical evaluation and the framework to identify sufficient clinical evidence throughout the lifecycle of a device.
Overview of covered topics
Purpose of the training
Participants will be enabled to
Who should attend
Basic knowledge required
Our trainers have long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting.
Dr. Susanne Gerbl-Rieger
AKRA TEAM GmbH
Dr. Anna Spehl
AKRA TEAM GmbH
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