The regulation of new medical devices

Loraine Holley, Cliff Hughes

Research output: Contribution to journalArticlepeer-review


This article sets out the results of a survey that was undertaken to determine if the processes of Institutional Ethics Committees were able to determine whether safe medical devices were being approved for use. Many IECs indicated they lacked technical expertise to consider many of the devices. This article discusses the legal and procedural implications of these findings, together with recommendations for reform.
Original languageEnglish
Pages (from-to)176-182
Number of pages6
JournalJournal of Law and Medicine
Publication statusPublished - Nov 1999
Externally publishedYes


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