Table 2 Important outputs and outcomes of the MDLC areas
Areas | Description | Outputs | Outcomes |
|---|---|---|---|
Regulation | Safety and efficacy are in the focus of this phase to aim population safety. Key elements are performing testing, safety assessment & post-market reporting using criteria of safety and quality standards. | Mandatory compliance | Assuring minimal standards of quality |
Assessment | Serving the population is in the focus of this phase to aim population health. Key elements are systematic analysis and critical review using epidemiology and evidence data. | Recommendations on highly complex technologies | Responsiveness and maximization of clinical outcomes and cost-effectiveness |
Management | Health service providers are in the focus of this phase. Key element is the operational management of technology life-cycle using needs analysis and reliable device availability for clinical use. | Operational rules and guidance for all medical devices | Improved health delivery; sustainable availability of high-quality and safe devices |