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Safe innovation: On medical device legislation in Europe and Africa
Univ Pisa, Res Ctr E Piaggio, Largo Lucio Lazzarino 1, I-56122 Pisa, Italy.;Univ Pisa, Dept Ingn Informaz, Pisa, Italy..
Univ Pisa, Res Ctr E Piaggio, Largo Lucio Lazzarino 1, I-56122 Pisa, Italy..
Univ Politecn Madrid, Mech Engn Dept, Madrid, Spain..
Kenyatta Univ, Dept Elect & Elect Engn, Nairobi, Kenya..
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2018 (English)In: Health Policy and Technology, ISSN 2211-8837, E-ISSN 2211-8845, Vol. 7, no 2, p. 156-165Article in journal (Refereed) Published
Abstract [en]

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. (C) 2018 Fellowship of Postgraduate Medicine.

Place, publisher, year, edition, pages
ELSEVIER SCI LTD , 2018. Vol. 7, no 2, p. 156-165
Keywords [en]
Medical devices regulation, Standards, Africa, Europe, Open Source Medical Devices
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:kth:diva-232260DOI: 10.1016/j.hlpt.2018.01.012ISI: 000436912800009Scopus ID: 2-s2.0-85042215600OAI: oai:DiVA.org:kth-232260DiVA, id: diva2:1233625
Note

QC 20180718

Available from: 2018-07-18 Created: 2018-07-18 Last updated: 2018-07-18Bibliographically approved

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Mridha, Mannan

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