Key points: 

• The EU Health Technology Assessment (HTA) Regulation (2021/2282) provides for harmonised European evaluation of new health technologies, aiming to support individual evidence-based reimbursement decisions at member state-level and to facilitate patient access 
• Joint clinical assessment (JCA), introduced in a staggered approach for different classes of medicinal products and medical devices, is based on a common methodology using defined population, intervention, comparator(s) and outcome(s) (PICOs) to describe the relative effectiveness and its certainty, while not including any value judgement 

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