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
- Applicability of Real World Data and Real World Evidence