The EU Health Technology Assessment Regulation (EU) 2021/2282 establishes Joint Clinical Assessments (JCAs) as a centralized framework for evaluating the clinical effectiveness and safety of health technologies across EU Member States.
For medical device manufacturers, one component of this process is especially critical: the PICO framework. By defining the Population, Intervention, Comparator, and Outcome, PICO sets the parameters of the entire assessment and is one of the most important determinants of JCA success.
As a foundational element of the JCA process, PICO translates the assessment scope into structured research questions and defines the evidence expectations placed on health technology developers. Once finalized, PICO becomes binding, making it the primary driver of evidence requirements.
PICO determines:
- What evidence must be submitted
- Which comparisons will be assessed
- How clinical results will be interpreted
Drawing on official European Commission guidance and published PICO exercises for medical devices, this White Paper provides an end-to-end view of the PICO development process and highlights the key methodological and strategic considerations for manufacturers.
The White Paper is particularly relevant for medical device manufacturers, market access leaders, clinical development teams, regulatory teams, evidence generation specialists, and senior decision-makers preparing for EU Joint Clinical Assessments.
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Request the analytical White Paper to gain a comprehensive understanding of the PICO scoping process and its implications for medical device manufacturers