Publication Digest: Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Albuquerque de Almeida et al. studied the regulatory framework differences between medical devices and drugs in the European Union and their impact on clinical and HTA research. The authors identified varying approval standards for devices and drugs as well as fewer manufacturer-sponsored clinical studies and HTA-supported recommendations for medical devices compared to drugs. The study concludes that policy changes, such as the consensual classification of medical devices from an HTA perspective and the adoption of conditional coverage practices, could promote an integrated evidence-based assessment system and improve resource allocation in healthcare.

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