Essentials of European Medical Device Regulatory Affairs

Newly introduced provisions

New obligations across stakeholders • Economic operators: Manufacturer,

Requirements & QMS • General Safety and Performance Requirements • Technical documentation • Clinical requirements • Quality management system

Eudamed & Traceability • European Database on Medical Devices (Eudamed) • Unique Device Identifier: Commission Implementing Decision (EU ) 2019/939 of 6 June 2019 contains the designated tools for assignment of UDI’s Authorized Representative, Importer & Distributor required to have sufficient financial coverage • Person responsible for regulatory compliance (Art. 15 MDR)

Classification

Rule 11 software

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• Rule 18 non-viable tissue of human or animal cells, • Rule 19 nanomaterials • Rule 20 inhalation of medicinal substances • Rule 21 substance-based devices • Rule 22 active therapeutic devices with an integrated diagnostic function

The Organisationfor Professionals inRegulatory Affairs

The Transition Period and “The Grace Period”

The Organisationfor Professionals inRegulatory Affairs