Regulation of medical implants in the EU and UK. Vol 1: Report, together with formal minutes, oral and written evidence. Vol 2: Additional written evidence

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Series Title
Series Details (2012-13)HC 163
Publication Date 2012
ISBN 978-0-21-504974-2 (Vol I)
Content Type

Following the introductory first chapter, chapter 2 of this report outlines the requirements of the European Directives relating to medical devices and how implants are regulated in the UK as a result. Chapter 3 considers the process of certifying products for the EU market: whether sufficient evidence is gathered on an implant before approval for use and whether tighter pre-market requirements would introduce barriers to innovation and prevent the latest technology from reaching patients. Chapter 4 considers how to improve the monitoring of medical implants once they are on the market (post-market surveillance), and increasing coordination between EU Member States. Finally, overall conclusions are drawn in chapter 5.

Source Link Link to Main Source http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/16302.htm
Related Links
United Kingdom: House of Commons: Science and Technology Committee: 5th Report (2012-13)HC 163-I http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/163.pdf
United Kingdom: House of Commons: Science and Technology Committee: 5th Report (2012-13)HC 163-II http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/163vw.pdf
United Kingdom: Parliament: House of Commons: Committees: Press Release, 1.12.12: Tighten safety on medical implants - Ministers urged http://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news/121101-medical-implants-report-published/

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