EU MDR 2017/745

  • Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
  • 3 year transition period in effect until May 2021 for manufacturers who currently sell CE marked devices in the EU.  (See note below)
  • Beefed up requirements for post-market surveillance, labeling, clinical evaluations (list is not all-inclusive).  New requirements including economic operators and contents of technical documentation, regulatory plan.
  • Essential Requirements in 93/42 EEC and 90/385/EEC have been replaced with General Safety and Performance Requirements (GSPRs)

NOTE:  Due to the COVID-19 pandemic, DoA (Date of Application) for EU MDR has been delayed to May 26, 2021.  Please note: This does not mean that all requirements have been pushed back accordingly.