Medical Device Regulation

  • 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 2020 for manufacturers who currently sell CE marked devices in the EU.
  • Beefed up requirements for post-market surveillance, labeling,
  • Essential Requirements in 93/42 EEC and 90/385/EEC have been replaced with Safety and Performance Requirements (SPRs)