Medical Device Regulation

Key Facts:

  • Scope has been expanded to include aesthetic devices
  • Classification system remains relatively unchanged with the addition of some new rules
  • Notified Bodies must become accredited under the Medical Device Regulation
  • Authorized Representatives must meet upgraded requirements and have a designated Person Responsible for Regulatory Compliance (PRRC)
  • Introduction of Unique Device Identification (UDI) requirement
  • Deadline to comply under MDR - May 2020 or before the expiration of CE Certificate issued under MDD 93/42/EEC
  • MDD I manufacturers will be required to create and continually update Clinical Evaluation Report (CER)

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