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The rise of rules: Will the new EU regulation of medical devices make us safer?

  • R. Tarricone
    Correspondence
    Corresponding author.
    Affiliations
    Department of Social and Political Science, Bocconi University, Via Roentgen 1, Milan 20136, Italy

    Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Via Sarfatti 10, Milan 20136, Italy
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  • O. Ciani
    Affiliations
    Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Via Sarfatti 10, Milan 20136, Italy

    College of Medicine and Health, University of Exeter, Stocker Rd, Exeter EX4 4PY, United Kingdom
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  • S. D'Acunto
    Affiliations
    Directorate General GROW, European Commission, Avenue d'Auderghem 45, Etterbeek 1040, Belgium
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  • S. Scalzo
    Affiliations
    Directorate General GROW, European Commission, Avenue d'Auderghem 45, Etterbeek 1040, Belgium
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      Whenever markets fail and minimum level of quality must be guaranteed to consumers, users and the system as a whole, regulations are needed. This is undoubtedly the case for healthcare technologies, where factors such as information asymmetries, externalities, economies of scale or uneven compliance with protection rules prevent markets from functioning efficiently [
      • Donaldson C
      • Gerard K.
      Economics of health care financing.
      ,
      • Roberts J.
      The marketers and the National Health Service.
      ].
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