Table 1 EE Studies by type of device assessed, purpose of device, EU risk class and targeted pediatric group. Medical Device Risk Classification according to the new EU Medical Device Regulation
Author (Publication Year) | Type of device assessed | Purpose of the device | Device EU risk class | Pediatric age group considered in the EE study |
|---|---|---|---|---|
Aburahma S (2015) | Vagus Nerve Stimulation device | Therapeutic | III | Infants, children and adolescents |
Cheng A (2000) | cochlear implant | Therapeutic | III | Infants and children |
O’Neill C (2000) | cochlear implant | Therapeutic | III | Infants and children |
Carter R (1999) | cochlear implant | Therapeutic | III | Infants and children |
Barton G (2006) | cochlear implant | Therapeutic | III | Infants and children |
Foteff C (2016) | cochlear implant | Therapeutic | III | Infants, children and adolescents |
Schulze-Gattermann H (2002) | cochlear implant | Therapeutic | III | infants and children |
Summerfield A (2010) | bilateral cochlear implant | Therapeutic | III | infants and children |
Ahmadi A (2013) | 3 types of cardiac duct occluders | Therapeutic | III | Infants, children and adolescents |
Brown K (2009) | ECMO device (as a bridge to transplant) | Life-supporting/Therapeutic | IIb | Infants, children and adolescents |
El-Saiedi S (2017) | 3 types of cardiac duct occluders | Therapeutic | III | infants and children |
Heidari S (2017) | auditory brainstem response device | Diagnostics | Iia | neonates |
Petrou S (2006) | ECMO | Life-supporting device | IIb | neonates |
Mahle W (2008) | Ventricular Assisting Device | Therapeutic | III | neonates, infants, children and adolescents |
Campbell K (2007) | Head Computed Tomography (CT) | Diagnostics | IIb | Infants |
Chen A (2014) | bubble CPAP device | Life-supporting/Therapeutic | IIb | Neonates |
Huang L (2018) | CPAP device | Life-supporting/Therapeutic | IIb | preterms |
Santiago Medina L (2001) | diagnostic imaging equipment (MRI, CT, XR) | Diagnostics | IIa and IIb | Neonates |
von Keyserlingk K (2011) | wrist splints | Therapeutic | I | infants and children |
Santiago Medina L (2002) | 3D CT equipment | Diagnostics | IIb | infants and children |
Saunders J (2015) | cochlear implant | Therapeutic | III | infants and children |
Emmet S (2015) | cochlear implant | Therapeutic | III | infants and children |
Pérez-Martin J (2017) | bilateral cochlear implant | Therapeutic | III | Infants |
Avanceña A (2021) | implantable ventricular assisting device | Therapeutic | III | adolescents |
Cheng L (2019) | bilateral cochlear implant | Therapeutic | III | Infants, children and adolescents |
Fang T (2019) | unilateral cochlear implant + contralateral acoustic hearing aid | Diagnostics | Iia | Children and adolescents |
Trujillo, D (2019) | pulse oximeter | Life-supporting/Therapeutic | Iia | Neonates |
Mowitz, M (2017) | nasal continuous positive pressure device | Diagnostics | Iia | Neonates |
Narayen, I (2019) | pulse oximeter | Diagnostics | Iia | Neonates |
Peterson, C (2013) | pulse oximetry | Therapeutic | III | Neonates |
Qiu, J (2017) | cochlear implant | Diagnostics | Iia | Infants and children |
Roberts, T (2012) | pulse oximeter | Diagnostics | Iia | Neonates |
Tobe, R (2017) | pulse oximeter | Diagnostics | Iia | Neonates |
Mukerji, A (2020) | pulse oximeter | Life supporting/Therapeutic | III | Neonates |
Evers, P (2019) | The continuous-flow ventricular assist device | Life supporting/Therapeutic | III | children |
BuendÃa, J. (2021) | High-flow nasal cannula | Life supporting/Therapeutic | IIb | Infants, children and adolescents |
Huang, L (2021) | nasal CPAP device | Life-support/Therapeutic | IIb | Neonates |
Feingold, B (2010) | Implantable cardioverter-defibrillators | Life-support/Therapeutic | III | Infants, children and adolescents |
Neves, L (2021) | wide-field imaging + indirect binocular ophthalmoscopy | Diagnostics | Iia | preterms |