Medical devices are classified based on associated risks and established mode of action (MOA). Such a classification determines the conformity assessment route and applicable regulatory/clinical/quality requirements.

Within a rapidly evolving regulatory scene, medical devices are under high scrutiny – regulatory requirements are currently being reinforced, in particular to ensure patient safety (clinical evidence, vigilance and market surveillance).

The ongoing transition from a fee-for-service model to a fee-for-value system incentivizes outcomes over technological inputs, and requires an increasingly sound demonstration of clinical and economic value to health care systems.

Key challenges encompass:

  • Product qualification/classification
  • Communication with Regulatory Authorities
  • Market clearance routes
  • Indications for use
  • Safety & Performance claims
  • Risks analysis and risk management plan
  • Biocompatibility and clinical evidence demonstration
  • Post Market Surveillance (PMS)
  • Quality Management System (QMS)
  • Market access strategy and value demonstration to payers