lack of innovation due to the strict regulations; this is the case of X-Ray machines innovation critics [@ekelman1988technological]. On the other side of the Atlantic, the European Union adopted the MDD (Medical Device Directive) as the governing set of standards and regulations for medical-devices manufacturer. Some of these directives are the Medical Device Directive (MDD 93/42/EEC), the In Vitro Diagnostic Medical Device Directive (IVDMDD98/79/EC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) [@french2012medical]. Overall, in different countries, regulation have gone through different paths; however, those countries most involved in medical device regulation established the Global Harmonization Task Force (GHTF) and, after that, the International Medical Device Regulators Forum (IMDRF) [@IMDRF] appeared with the goal of enforcing a faster medical device regulatory harmonization and convergence at international level in what concerns safety, performance and quality of medical devices.

According to the EU Borderline Manual [@manualborder], the following types of software should generally be classified as medical devices:

-   picture archiving and communication systems;

-   mobile apps for processing ECGs;

-   software for delivery and management of cognitive remediation and rehabilitation programs;

-   software for information management and patient monitoring; and

-   mobile apps for the assessment of moles (e.g. making 