Application of the Medical Device Directive to Software: Methodological Challenges

被引：1

作者：

Pelayo, Sylvia ^{[1
]}

Da Costa, Sabrina Bras ^{[1
,2
]}

Leroy, Nicolas ^{[1
]}

Loiseau, Severine ^{[1
]}

MacKeon, Damien ^{[2
]}

Trancard, Delphine ^{[2
]}

Beuscart-Zephir, Marie-Catherine ^{[1
]}

机构：

[1] CHRU Lille, CIC IT Lille, EVALAB, Batiment Hippoerate,150-154 Rue Doeteur Yersin, F-59120 Loos, France

[2] Univ Montpellier 3, InterPsy ETIC EA 4432, F-57006 Metz 1, France

来源：

MEDINFO 2013: PROCEEDINGS OF THE 14TH WORLD CONGRESS ON MEDICAL AND HEALTH INFORMATICS, PTS 1 AND 2 | 2013年 / 192卷

关键词：

Patient Safety; Risk Management; Human Engineering; Standards; Evaluation Studies;

D O I：

10.3233/978-1-61499-289-9-437

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

The European Union (EU) adopted the revised Medical Device Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medical device (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures.

引用

页码：437 / 441

页数：5

共 50 条

[41] The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics
Beckers, R.
Kwade, Z.
Zanca, F.
PHYSICA MEDICA-EUROPEAN JOURNAL OF MEDICAL PHYSICS, 2021, 83 : 1 - 8
[42] Regulating the circular economy within the ecodesign directive: Progress so far, methodological challenges and outlook
Polverini, Davide
SUSTAINABLE PRODUCTION AND CONSUMPTION, 2021, 27 : 1113 - 1123
[43] Medical device presents molding, testing challenges
Destefani, JD
MOLDING SYSTEMS, 1998, 56 (05): : 26 - 29
[44] Challenges and Opportunities in Shaping Medical Device Epidemiology
Marinac-Dabic, Danica
Sedrakyan, Art
Ritchey, Mary E.
Normand, Sharon-Lise
Resnic, Frederic
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2010, 19 : S331 - S332
[45] Academic/Industry Challenges for Medical Device Development
Linehan, John H.
Chaney, Ari
SCIENCE TRANSLATIONAL MEDICINE, 2010, 2 (63)
[46] Book review: Application of the Medical Devices Directive - Guidance Notes
Phys Med Biol, 4 (759):
[47] NEW EUROPEAN MEDICAL DEVICE DIRECTIVE AND THE POTENTIAL CONSEQUENCES FOR US AND EUROPEAN MANUFACTURERS
Ehreth, J.
Mueller, E.
Neeser, K.
VALUE IN HEALTH, 2017, 20 (05) : A252 - A252
[48] Risk Assessment and Classification of Medical Device Software for the Internet of Medical Things
Brass, Irina
Mkwashi, Andrew
PROCEEDINGS OF THE 12TH INTERNATIONAL CONFERENCE ON THE INTERNET OF THINGS 2022, IOT 2022, 2022, : 171 - 178
[49] Comparing attributes of the ASEAN medical device directive and EU 2017/745 regulation
Schoener B.
Hoxey E.
Biomedical Instrumentation and Technology, 2019, 53 (03): : 208 - 213
[50] Managing Requirements Baselines for Medical Device Software Development
Wong, Ken
Callaghan, Christine
2012 IEEE INTERNATIONAL SYSTEMS CONFERENCE (SYSCON), 2012, : 479 - 483

← 1 2 3 4 5 →