Evidence-based Clinical and Pre-Clinical Strategies for the Evaluation of Medical Devices
Surveys
We need your help!
If you have experience with clinical evaluation and / or any of the following device groups, please answer one or more of our surveys!
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Which medical devices really need clinical data for initial CE-marking?
For which devices may data from the generic device group together with advanced testing be enough for initial CE-marking?
Is advanced non-clinical testing better suited to support patient safety than pre-market clinical data for some devices?
What do advanced non-clinical testing strategies look like?
What is the role of PMCF in this context?
Background
The original Medical Device Directive (MDD, Council Directive 93/42/EEC) required clinical data “in particular” for implantable and Class III devices. It was only in 2007 that a clinical evaluation requirement was introduced for all medical devices. This culminated in the publication of the Medical Device Regulation (MDR, Regulation EU 2017/745) in 2017, spurred by high-profile device failures involving metal-on-metal hip implants and substandard silicone breast implants.
Despite these regulatory advances, significant uncertainty remains around the appropriate level of clinical evidence required for different types of devices. This lack of consensus affects manufacturers, notified bodies, and ultimately, patient safety.
ECliPSE seeks to resolve this ambiguity by developing robust, evidence-based strategies that define when and how clinical and non-clinical data should be used in medical device evaluation.
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