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Defining innovativeness of high-technology medical devices in an Italian region
  1. Andrea Messori1,
  2. Sabrina Trippoli2,
  3. Laura Bartoli3,
  4. Claudio Marinai3
  1. 1 HTA Unit, Regione Toscana, Firenze, Italy
  2. 2 Pharmaceutical Sciences, Regione Toscana, Firenze, Toscana, Italy
  3. 3 Regione Toscana, Firenze, Toscana, Italy
  1. Correspondence to Dr Andrea Messori, HTA Unit, Regione Toscana, 50129 Firenze, Italy;{at}

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In the field of medical devices, innovation has been debated to a much less extent when compared with pharmaceutical products. In Italy, the regulation of innovative pharmaceutical products was established in 2017, through a resolution1 issued by the national medicines agency (AIFA) after the adoption of a national law.2 According to this regulation, innovative medicines (reported in a national list3) are made immediately available to patients, even without formal inclusion in the regional hospital therapeutic schedules.

As regards medical devices, a first attempt to issue a regulation on innovative devices has been made at the regional level in the Tuscany region. A multidisciplinary group of healthcare professionals (eight members of the so-called ‘Gruppo Regionale permanente sui dispositivi …

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  • Contributors The four authors contributed equally to this letter.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.