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Regulatory Affairs, Medical Devices

EU MDR: New expectations for clinical evaluations and investigations - WHITEPAPER


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In May 2020 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.

This whitepaper assesses new expectations for clinical evaluations and investigations under the EU MDR including:

  • The key differences between MDD and the MDR requirements for clinical evaluations and investigations

  • Understanding what Competent Authorities and Notified Bodies are looking for

  • Assessing the requirements for legacy devices under the MDR

  • Evaluating and rationalising product portfolios

  • Key challenges and opportunities with the new clinical requirements

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