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Research Papers

Changes to the International Regulatory Environment

[+] Author and Article Information
Martin McHugh

Regulated Software Research Group & Lero, Department of Mathematics and Computing,  Dundalk Institute of Technology, Dundalk Co. Louth, IrelandMartin.McHugh@dkit.ie

Fergal McCaffery

Regulated Software Research Group & Lero, Department of Mathematics and Computing,  Dundalk Institute of Technology, Dundalk Co. Louth, IrelandFergal.McCaffery@dkit.ie

Valentine Casey

Regulated Software Research Group & Lero, Department of Mathematics and Computing,  Dundalk Institute of Technology, Dundalk Co. Louth, IrelandVal.Casey@dkit.ie

J. Med. Devices 6(2), 021004 (Apr 26, 2012) (4 pages) doi:10.1115/1.4006592 History: Received August 05, 2011; Revised February 22, 2012; Published April 26, 2012; Online April 26, 2012

Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of an amendment to the directive have a direct impact on the development of medical devices. One of the most significant changes as part of this amendment is for software to be potentially considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas, such as the use of mobile device applications for healthcare purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of.

Copyright © 2012 by American Society of Mechanical Engineers
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