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New Medical Devices Regulation now published

On April 5, 2017 the EU adopted the new Medical Devices Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation will enter into force after a three-year transition period ending in spring 2020. This means that the market access framework for all member countries of the European single market will change significantly.

Key Changes

Notified Bodies
  • Strengthened designation criteria
  • Joint audits: 3 Member States and Commission (FHAA)
  • Unannounced audits
Clinical evidence
  • Less equivalence, more data for high risk devices
  • Publish Safety and Performance data
  • Post-market clinical follow-up
  • Scrutiny for high risk devices
  • Common Specifications
  • Responsible person for manufacturers and Authorized Representatives
Post-market surveillance and vigilance
  • Central database and co-ordination
  • Trend reporting
  • Enforcement activities
Transparency and traceability
  • Devices and Economic Operators registered centrally
  • Unique Device Identification (UDI)
  • Implant cards, SSCP
Governance and oversight
  • Central Committee: MDCG
  • Expert Panel, Expert Laboratories