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MTRC has released a White Paper “PICO in EU Joint Clinical Assessments for Medical Devices”
MTRC has released a White Paper titled “PICO in EU Joint Clinical Assessments for Medical Devices: An Overview of the Implications of PICO Scoping for Medical Device Companies.” The White Paper explains the role of the PICO framework in Joint Clinical Assessments under the EU Health Technology Assessment Regulation (EU) 2021/2282.
For medical device manufacturers, PICO - Population, Intervention, Comparator, and Outcome - defines the assessment scope and evidence requirements. Once finalized, it becomes binding and determines:
- What evidence must be submitted
- Which comparisons will be assessed
- How clinical results will be interpreted
Based on official European Commission guidance and published PICO exercises, the White Paper outlines the PICO development process and key methodological and strategic considerations for manufacturers.
It is particularly relevant for medical device manufacturers, market access, clinical development, regulatory, and evidence generation teams preparing for EU Joint Clinical Assessments.
Read more and request the White Paper here.