scholarly journals Medical Device Apps: An Introduction to Regulatory Affairs for Developers

10.2196/17567 ◽  
2020 ◽  
Vol 8 (6) ◽  
pp. e17567 ◽  
Author(s):  
Lina Keutzer ◽  
Ulrika SH Simonsson
Keyword(s):  
Medical Device ◽  
Transition Period ◽  
Mobile Apps ◽  
European Economic Area ◽  
Technical Documentation ◽  
Medical Device Development ◽  
Device Development ◽  
Regulatory Affairs ◽  
Medical Device Software

The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.

scholarly journals Medical Device Apps: An Introduction to Regulatory Affairs for Developers (Preprint)

2019 ◽  
Author(s):  
Lina Keutzer ◽  
Ulrika SH Simonsson
Keyword(s):  
Medical Device ◽  
Transition Period ◽  
Mobile Apps ◽  
European Economic Area ◽  
Technical Documentation ◽  
Medical Device Development ◽  
Device Development ◽  
Regulatory Affairs ◽  
Medical Device Software

UNSTRUCTURED The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.

Recent Statistical Contributions to Medical Device Development

2014 ◽  
Vol 48 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Brian L. Wiens ◽  
Theodore C. Lystig ◽  
Scott M. Berry
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

scholarly journals The medical device development landscape in South Africa: Institutions, sectors and collaboration

2017 ◽  
Vol 113 (5/6) ◽  
Author(s):  
Kylie de Jager ◽  
Chipo Chimhundu ◽  
Trust Saidi ◽  
Tania S. Douglas ◽  
◽  
...  
Keyword(s):  
South Africa ◽  
Medical Device ◽  
Centrality Measures ◽  
Collaboration Network ◽  
Medical Device Development ◽  
Device Development ◽  
Healthcare Needs ◽  
Scientific Papers ◽  
Future Policy ◽  
Local Healthcare

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa.

Engineering Design Controls for Efficient Medical Device Development

2008 ◽  
Author(s):  
Lisa Henn
Keyword(s):  
Medical Device ◽  
Early Stage ◽  
Design Team ◽  
Medical Device Development ◽  
Device Development ◽  
Development Teams ◽  
Final Design ◽  
Design Proposal ◽  
Effective Design ◽  
University Setting

Early stage medical device development teams investigate many alternatives before selecting a final design proposal. The team must be able to retrace and reproduce successful designs and understand factors that underpin decisions that came before. This is especially important in a university setting due to the natural turnover on the team that is inherent in a successful research group. Effective design control provides this support to the design team.

Using Value Stream Mapping to Improve Medical Device Development

2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Value Stream Mapping ◽  
Medical Device Development ◽  
Value Stream ◽  
Device Development

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.

scholarly journals Spinal dura mater: biophysical characteristics relevant to medical device development

2018 ◽  
Vol 42 (2) ◽  
pp. 128-139 ◽  
Author(s):  
Sean J. Nagel ◽  
Chandan G. Reddy ◽  
Leonardo A. Frizon ◽  
Matthieu K. Chardon ◽  
Marshall Holland ◽  
...  
Keyword(s):  
Medical Device ◽  
Dura Mater ◽  
Medical Device Development ◽  
Device Development

scholarly journals Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

2020 ◽  
Vol 12 (5) ◽  
pp. 1755 ◽  
Author(s):  
Petra Marešová ◽  
Lukáš Peter ◽  
Jan Honegr ◽  
Lukáš Režný ◽  
Marek Penhaker ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Medical Device ◽  
Stage Model ◽  
Concept Design ◽  
Development Stages ◽  
Medical Device Development ◽  
Device Development ◽  
Economic Methods ◽  
Financial Expenditure ◽  
Investment Process

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost–time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents’ responses, were conducted. The authors have proposed the complexity model MedDee—Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

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