MedTech Summit US - Comparing EU and FDA approaches

DIFFERENCES IN CLINICAL EVALUATIONS AND INVESTIGATIONS UNDER THE EU

The EU MDR officially replaces the Active Implantable Medical Device Directive and the Medical Device Directive for medical devices. The EU MDR has a key objective of ensuring health and safety of EU citizens by making the medical device regulation more stringent with respect to the requirements for clinical investigation and evaluation. The definition (Article 2 EU MDR) regarding the term ‘medical device’ has been modified in the EU MDR as against the definition in the MDD. For example, terminologies such as the Unique Device Identifier, clinical data, clinical evidence, and serious incident have been affected by the changes in the EU MDR. Clinical evaluation for medical devices is necessary to receive a CE mark which is imperative to market medical devices in the European Economic Area.

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November 18 - 20, 2019
Renaissance Chicago Downtown Hotel,
Chicago, IL