The combination of medical devices and medicinal products revisited from the new European legal framework

Antich-Isern, Pau; Caro-Barri, Julia; Aparicio-Blanco, Juan

doi:10.1016/j.ijpharm.2021.120992

Cited by 17 publications

(10 citation statements)

References 97 publications

(93 reference statements)

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“…Finally, two threats reached a consensus: (a) recreation and do-it-yourself misuse, which could lead to unexpected adverse events and safety issues (Sierawska et al, 2019); and (b) regulatory status, as medical devices require formal regulatory approval in the US (Darrow et al, 2021) and Europe (Antich-Isern et al, 2021), although some tES devices are marketed as wellness devices, have regulatory device exemptions (Bikson et al, 2018b), or can be approved by similarity (Bikson et al, 2018b). Further, mobile tES devices could have additional regulations, if framed as mobile Health systems (Onodera and Sengoku, 2018).…”

Section: Resultsmentioning

confidence: 99%

Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel

Brunoni

Fregni

2022

Preprint

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Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Device appraisal showed moderate digitalization readiness, with high safety and possibility of trial implementation, but low connectivity. Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; although they reached no consensus about aspects regarding methodological biases. We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.

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Section: Resultsmentioning

confidence: 99%

Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel

Brunoni

Fregni

2022

Preprint

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“…The use of metal salts and metal nanoparticles has also been implemented in many medical devices to control infections, with silver systems having significant applications in medical device development ( 20 , 21 ). However, there remains a growing interest in finding new antiseptic systems that potentially better manage safety concerns (e.g., reduced leaching of the antiseptic from the medical device) or better deal with new regulatory protocols ( 21 , 22 ).…”

Section: Discussionmentioning

confidence: 99%

New In Situ -Generated Polymer-Iodine Complexes with Broad-Spectrum Antimicrobial Activity

López‐Álvarez

Ulmer²,

Klay³

et al. 2022

Microbiol Spectr

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“…2017/745) y/o por una verificación de los productos (Anexo XI, parte B del Reglamento (UE) nº. 2017/745)) (26).…”

Section: Evaluación De La Conformidad Declaración Ue De Conformidad Y...unclassified

The borderline with medical devices in the current Spanish legal framework

Isern

Blanco

2022

an.ranf

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Medical devices cover a wide range of products essential for healthcare. In 2017 a new European regulation covering them was approved that fully applies from 2021 onwards. In it, their legal definition, classification, conformity assessment procedures, requirements for the clinical investigations that asses their safety and/or performance, and European database are specified. Despite the efforts for systematizing the legal definition of medical device in the new regulation, the determination of the legal status of devices known as ‘borderline products’, for which different regulations may apply (like in the borderline with food supplements, cosmetics, personal care products, biocides, personal protective equipment and consumer products), is not without difficulties. On account of their therapeutic significance, this review delves into the borderline between medicinal products and medical devices, and differentiates them from presentations where medicinal products and medical devices are used in combination, without constituting a borderline. Establishing updated definitions, promoting transparency in the sector and preventing conflicts of interest should motivate all stakeholders to the periodic review of the regulation in a field in continuous technological evolution and development.

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The combination of medical devices and medicinal products revisited from the new European legal framework

Cited by 17 publications

References 97 publications

Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel

Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel

New In Situ -Generated Polymer-Iodine Complexes with Broad-Spectrum Antimicrobial Activity

The borderline with medical devices in the current Spanish legal framework

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