Impact of Class I Software as Medical Devices (SaMDs) on Public Health

Marlon Machal

doi:10.3233/SHTI220652

Impact of Class I Software as Medical Devices (SaMDs) on Public Health

Marlon Machal

Tutkimustuotos: Konferenssiartikkeli › Scientific › vertaisarvioitu

1 Sitaatiot (Scopus)

90 Lataukset (Pure)

Abstrakti

There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement. It is unclear how these devices are monitored if they will undergo any significant changes. Significant change may shift existing low-risk class I SaMDs to higher risk classification. In another hand, it is not clear if all class I SaMDs that are certified under MDD are registered with relevant EU Competent Authorities. Class I SaMDs may have an impact on public health if they are not known and monitored by European competent authorities.

Alkuperäiskieli	Englanti
Otsikko	Advances in Informatics, Management and Technology in Healthcare
Toimittajat	John Mantas, Parisis Gallos, Emmanouil Zoulias, Arie Hasman, Mowafa S. Househ, Marianna Diomidous, Joseph Liaskos, Martha Charalampidou
Kustantaja	IOS Press
Sivut	33 -36
Sivumäärä	4
Vuosikerta	295
ISBN (elektroninen)	978-1-64368-291-4
ISBN (painettu)	978-1-64368-290-7
DOI - pysyväislinkit	https://doi.org/10.3233/SHTI220652
Tila	Julkaistu - 29 kesäk. 2022
OKM-julkaisutyyppi	A4 Artikkeli konferenssijulkaisussa
Tapahtuma	International Conference on Informatics, Management, and Technology in Healthcare - Athens, Kreikka Kesto: 1 heinäk. 2022 → 3 heinäk. 2022

Julkaisusarja

Nimi	Studies in Health Technology and Informatics
Vuosikerta	295
ISSN (painettu)	0926-9630
ISSN (elektroninen)	1879-8365

Conference

Conference	International Conference on Informatics, Management, and Technology in Healthcare
Maa/Alue	Kreikka
Kaupunki	Athens
Ajanjakso	1/07/22 → 3/07/22

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10.3233/SHTI220652Lisenssi: CC BY-NC

SHTI-295-SHTI220652-1Final published version, 134 KBLisenssi: CC BY-NC

https://urn.fi/URN:NBN:fi:tuni-202211248611Lisenssi: CC BY-NC

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Machal, M. (2022). Impact of Class I Software as Medical Devices (SaMDs) on Public Health. teoksessa J. Mantas, P. Gallos, E. Zoulias, A. Hasman, M. S. Househ, M. Diomidous, J. Liaskos, & M. Charalampidou (Toimittajat), Advances in Informatics, Management and Technology in Healthcare (Vuosikerta 295, Sivut 33 -36). (Studies in Health Technology and Informatics; Vuosikerta 295). IOS Press. https://doi.org/10.3233/SHTI220652

Machal, Marlon. / Impact of Class I Software as Medical Devices (SaMDs) on Public Health. Advances in Informatics, Management and Technology in Healthcare. Toimittaja / John Mantas ; Parisis Gallos ; Emmanouil Zoulias ; Arie Hasman ; Mowafa S. Househ ; Marianna Diomidous ; Joseph Liaskos ; Martha Charalampidou. Vuosikerta 295 IOS Press, 2022. Sivut 33 -36 (Studies in Health Technology and Informatics).

@inproceedings{b33fd8f17b3f4d8395c87766d678e507,

title = "Impact of Class I Software as Medical Devices (SaMDs) on Public Health",

abstract = "There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement. It is unclear how these devices are monitored if they will undergo any significant changes. Significant change may shift existing low-risk class I SaMDs to higher risk classification. In another hand, it is not clear if all class I SaMDs that are certified under MDD are registered with relevant EU Competent Authorities. Class I SaMDs may have an impact on public health if they are not known and monitored by European competent authorities.",

keywords = "SaMD, Risk, Public Threat",

author = "Marlon Machal",

note = "JUFOID=67818 Advances in Informatics, Management and Technology in Healthcare {\textcopyright} 2022 The authors and IOS Press. ; International Conference on Informatics, Management, and Technology in Healthcare ; Conference date: 01-07-2022 Through 03-07-2022",

year = "2022",

month = jun,

day = "29",

doi = "10.3233/SHTI220652",

language = "English",

isbn = " 978-1-64368-290-7",

volume = "295",

series = "Studies in Health Technology and Informatics",

publisher = "IOS Press",

pages = "33 --36",

editor = "John Mantas and Parisis Gallos and Emmanouil Zoulias and Arie Hasman and Househ, {Mowafa S.} and Marianna Diomidous and Joseph Liaskos and Martha Charalampidou",

booktitle = "Advances in Informatics, Management and Technology in Healthcare",

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Machal, M 2022, Impact of Class I Software as Medical Devices (SaMDs) on Public Health. julkaisussa J Mantas, P Gallos, E Zoulias, A Hasman, MS Househ, M Diomidous, J Liaskos & M Charalampidou (toim), Advances in Informatics, Management and Technology in Healthcare. Vuosikerta 295, Studies in Health Technology and Informatics, Vuosikerta 295, IOS Press, Sivut 33 -36, International Conference on Informatics, Management, and Technology in Healthcare, Athens, Kreikka, 1/07/22. https://doi.org/10.3233/SHTI220652

Impact of Class I Software as Medical Devices (SaMDs) on Public Health. / Machal, Marlon.
Advances in Informatics, Management and Technology in Healthcare. toim. / John Mantas; Parisis Gallos; Emmanouil Zoulias; Arie Hasman; Mowafa S. Househ; Marianna Diomidous; Joseph Liaskos; Martha Charalampidou. Vuosikerta 295 IOS Press, 2022. s. 33 -36 (Studies in Health Technology and Informatics; Vuosikerta 295).

Tutkimustuotos: Konferenssiartikkeli › Scientific › vertaisarvioitu

TY - GEN

T1 - Impact of Class I Software as Medical Devices (SaMDs) on Public Health

AU - Machal, Marlon

PY - 2022/6/29

Y1 - 2022/6/29

N2 - There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement. It is unclear how these devices are monitored if they will undergo any significant changes. Significant change may shift existing low-risk class I SaMDs to higher risk classification. In another hand, it is not clear if all class I SaMDs that are certified under MDD are registered with relevant EU Competent Authorities. Class I SaMDs may have an impact on public health if they are not known and monitored by European competent authorities.

AB - There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement. It is unclear how these devices are monitored if they will undergo any significant changes. Significant change may shift existing low-risk class I SaMDs to higher risk classification. In another hand, it is not clear if all class I SaMDs that are certified under MDD are registered with relevant EU Competent Authorities. Class I SaMDs may have an impact on public health if they are not known and monitored by European competent authorities.

KW - SaMD

KW - Risk

KW - Public Threat

U2 - 10.3233/SHTI220652

DO - 10.3233/SHTI220652

M3 - Conference contribution

SN - 978-1-64368-290-7

VL - 295

T3 - Studies in Health Technology and Informatics

SP - 33

EP - 36

BT - Advances in Informatics, Management and Technology in Healthcare

A2 - Mantas, John

A2 - Gallos, Parisis

A2 - Zoulias, Emmanouil

A2 - Hasman, Arie

A2 - Househ, Mowafa S.

A2 - Diomidous, Marianna

A2 - Liaskos, Joseph

A2 - Charalampidou, Martha

PB - IOS Press

T2 - International Conference on Informatics, Management, and Technology in Healthcare

Y2 - 1 July 2022 through 3 July 2022

ER -

Machal M. Impact of Class I Software as Medical Devices (SaMDs) on Public Health. julkaisussa Mantas J, Gallos P, Zoulias E, Hasman A, Househ MS, Diomidous M, Liaskos J, Charalampidou M, toimittajat, Advances in Informatics, Management and Technology in Healthcare. Vuosikerta 295. IOS Press. 2022. s. 33 -36. (Studies in Health Technology and Informatics). doi: 10.3233/SHTI220652

Impact of Class I Software as Medical Devices (SaMDs) on Public Health

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Julkaisusarja

Conference

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