Since the early 1990s, the European Community has harmonized national regulatory frameworks to provide regulatory guidance for the classification of MD that are placed on the markets of the European Economic Area (EEA). Currently, MD designed for children must fulfil the same regulatory framework as MD for adults to enter the commercial market. Different directives and regulations have been issued to regulate MD
[24][19], active implantable MD
[25][20], and in vitro diagnostic MD
[26][21]. In 2017, following the convergence of national regulatory frameworks on MD, the Regulation (EU) 2017/745 was published
[2][22]. The regulation states specific provisions need to be in place to protect vulnerable patients, including CYP, which is fulfilled by the need to conduct clinical trials in these populations. Any clinical trial involving CYP must be able to initially demonstrate a potential benefit from their participation and must include their informed consent according to their age and maturity. However, unlike the FDA that has released guidance specifically for the development of pediatric MD assessment
[27][23], no specific European guidance exists to manage research on MD in children or other vulnerable populations. Guidelines on clinical investigation and clinical evaluation (MEDDEV (MEDical DEVices) guideline 2.7/1 rev. 4, MDCG (Medical Device Coordination Group) guidelines from 2020-5 to 2020-13)
[28,29][24][25] merely emphasize the need for establishing protocols able to assess the clinical evidence on the device efficacy and safety on the basis of the peculiarities of target population groups (e.g., pediatric populations). Similarly, few ISO standards are available for the development of MD in children
[30][26]. In this context, it is noteworthy that article 106 of Regulation (EU) 2017/745 allows the European Commission, in consultation with the MDCG, to address these existing gaps by designating expert panels and laboratories on the basis of their up-to-date clinical, scientific, or technical expertise in the field to contribute to the development of appropriate guidance and common specifications on specific topics (e.g., clinical investigations, performance studies, biocompatibility) for specific devices in specific populations.