Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices
In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
IEEE journal of biomedical and health informatics - 26(2022), 11 vom: 23. Nov., Seite 5282-5286 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pappalardo, Francesco [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 14.11.2022 Date Revised 14.11.2022 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1109/JBHI.2022.3198145 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM344709000 |
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| 520 | |a In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing | ||
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| 700 | 1 | |a Geris, Liesbet |e verfasserin |4 aut | |
| 700 | 1 | |a Viceconti, Marco |e verfasserin |4 aut | |
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