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)


the most extensive and up-to-date database on European MDR laws! Have a look!

Learn More:

Stay up to speed with the latest regulatory news in the medical device industry! Sign up for a free cost projection now!

Your Free Cost Projection