Safe innovation: On medical device legislation in Europe and Africa

María, Carmelo de and Pietro, Licia Di and Díaz Lantada, Andrés and Madete, June and Makobore, Philippa Ngaju and Mridha, Mannan and Ravizza, Alice and Torop, Janno and Ahluwalia, Arti (2018). Safe innovation: On medical device legislation in Europe and Africa. "Health Policy and Technology", v. 7 (n. 2); pp. 156-165. ISSN 2211-8837. https://doi.org/10.1016/j.hlpt.2018.01.012.

Description

Title: Safe innovation: On medical device legislation in Europe and Africa
Author/s:
  • María, Carmelo de
  • Pietro, Licia Di
  • Díaz Lantada, Andrés
  • Madete, June
  • Makobore, Philippa Ngaju
  • Mridha, Mannan
  • Ravizza, Alice
  • Torop, Janno
  • Ahluwalia, Arti
Item Type: Article
Título de Revista/Publicación: Health Policy and Technology
Date: 2018
ISSN: 2211-8837
Volume: 7
Subjects:
Freetext Keywords: Medical devices regulation; Standards; Africa; Europe; Open Source Medical Devices
Faculty: E.T.S.I. Industriales (UPM)
Department: Ingeniería Mecánica
Creative Commons Licenses: Recognition - No derivative works - Non commercial

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Abstract

Objectives: The principal motivation for regulating medical devices is to protect patients and users. Complying with regulations may result in an increase in development, manufacturing and service costs for medical companies and ultimately for healthcare providers and patients, limiting the access to adequate medical equipment. On the other hand, poor regulatory control has resulted in the use of substandard devices. This study aims at comparing the certification route that manufactures have to respect for marketing a medical device in some African Countries and in European Union. Methods: We examined and compared the current and future regulations on medical devices in the European Union and in some countries in Africa. Contextually we proposed future approaches to open design strategies supported by emerging technologies as a means to enhance economically sustainable healthcare system driven by innovation. Results: African medical device regulations have an affinity to European directives, despite the fact that the latter are particularly strict. Several states have also implemented or harmonized directives to medical device regulation, or have expressed interest in establishing them in their legislation. Open Source Medical Devices hold a great promise to reduce costs but do need a high level of supervision, to control their quality and to guarantee their respect for safety standards. Conclusion: Harmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation.

Funding Projects

TypeCodeAcronymLeaderTitle
Horizon 2020731053UBORAUnspecifiedEuro-African Open Biomedical Engineering e-Platform for Innovation through Education

More information

Item ID: 54948
DC Identifier: http://oa.upm.es/54948/
OAI Identifier: oai:oa.upm.es:54948
DOI: 10.1016/j.hlpt.2018.01.012
Official URL: https://www.sciencedirect.com/science/article/pii/S2211883718300303?via%3Dihub
Deposited by: Memoria Investigacion
Deposited on: 10 May 2019 16:37
Last Modified: 10 May 2019 16:37
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