EU MDR 2017/745

  • Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
  • The regulation went into effect May 26, 2021 (Date of Application). This date was delayed due to COVID.
  • Requirements for companies that currently hold an MDD.AIMD certificate are detailed in Article 120.
  • Some of the new requirements of the MDR include:
      • Designation of a PRRC (person responsible for regulatory compliance)
      • Increased responsibilities for importers, distributors, and Authorized Representative (collectively, they are “economic operators”)
      • Much more robust requirements for post-market surveillance activities including the generation of specific records
      • Device classification rules
      • Essential Requirements in the MDD and 90/85 EC are replaced by the General Safety and Performance Requirements (GSPR)
      • Implementation of the EUDAMED database to collect and share information regarding medical device manufacturers and their devices
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